Clinical trial NCT01192568
Conditions: Overactive Detrusor Neurogenic Bladder
Sponsor: AbbVie
Start date: 2011-05-17; Completion date: 2023-10-24
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.

Detailed description:
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition

Arms: arm 1: Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks.

Followed by OL OTG for 8 weeks. arm 2: Open-Label Oxybutynin Chloride topical gel (OTG) (Pre \& Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks. arm 3: Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.
Interventions: intervention 1: Oxybutynin intervention 2: Placebo
Intervention descriptions: intervention 1: 10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally. intervention 2: Topical gel

Protocol documents:
Prot_000.pdf: 


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Investigator Statement
I have read this protocol and understand its requirements. I agree to conduct the study as 
described herein and will not deviate from the protocol without prior written approval from the 
sponsor or designee. Any protocol changes must be made by written amendment to the protocol 
and will not be implemented until approved by the institutional review board or ethics 
committee.
Principal Investigator Signature
Date
Printed Name


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Protocol Amendment Summary of Changes 
DOCUMENT HISTORY
Document
Date
Amendment 4
31 Oct 2022
Amendment 3
27 Sep 2016
Amendment 2
25 Jun 2012
Amendment 1
24 Nov 2010
Original Protocol
01 Sep 2010
Amendment 4 (
)
The purpose of Global Protocol Amendment 4 is to include administrative change, to update 
recent changes in Sponsor Contact and Medical Contact/TAMD for the study and information on 
the Contact Page updating email and phone number to address Safety concerns.
The following is a summary of changes made in Global Protocol Amendment 4. Strikethrough 
text denotes text removed and bolded text denotes added text. Additional administrative edits 
were also made, but not specifically noted (eg, corrected spelling, punctuation, grammar, 
abbreviation, and style errors) including global edits required for consistency.








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Protocol Section(s) 
Description of Changes
Rationale for Changes
Immediate Reporting of Serious 
Adverse Events and Events of 
Special Interest

Updated changes in reporting SAE under section 9.7.1.5.

Following information is removed
Fax the SAE Form for Clinical Trials to Allergan n Sales, LLC.
Global fax number for SAE or Pregnancy Reporting: 
1-714-796-9504 (backup fax 1-714-246-5295)
or email it to IR-Clinical-SAE@allergan.com.
In case of fax failure or the site does not receive confirmation of receipt of the fax, the 
site must email the report to IR-Clinical-SAE@allergen.com.

Added the following information
Fax the SAE Form for Clinical Trials to AbbVie Inc.
Global fax number for SAE or Pregnancy Reporting: 
1-714-796-9504 (backup fax 1-714-246-5295)
or email it to IR-Clinical-SAE@abbvie.com.
In case of fax failure or the site does not receive confirmation of receipt of the fax, the 
site must email the report to IR-Clinical-SAE@abbvie.com.

To reflect current information




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2
SYNOPSIS
Sponsor:
AbbVie Inc.
Name of Finished Product:
oxybutynin chloride gel
Name of Active Ingredient:
oxybutynin chloride
Study Title:
A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, 
Pharmacodynamics, and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment 
of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients
Study Number:
OG09002
Study Phase: Phase 4
Two-part Study:
This study will be conducted in 2 parts, Pre-Amendment 3 and Post-Amendment 3, as follows:

Pre-Amendment 3: A double-blind, randomized, placebo-controlled treatment study with 
open-label extension. Patients will be enrolled into the 6-week placebo-controlled 
treatment followed by an 8-week open-label treatment phase.

Post-Amendment 3: An open-label treatment study. Patients will be enrolled in a 6-week 
open-label treatment phase. A portion of enrolled patients will receive an additional 
8 weeks of open-label treatment for a total of 14 weeks of open-label treatment.
Primary Objectives:
The primary objectives are:

Pre-Amendment 3: To evaluate the efficacy of daily treatment with oxybutynin chloride 
gel compared to placebo in pediatric patients during the first 6 weeks of a 14-week 
treatment period.

Post-amendment 3: To evaluate the efficacy of daily treatment with oxybutynin chloride 
gel in pediatric patients during the first 6-weeks of a 14-week open-label treatment 
period.
Secondary Objectives (for Pre-Amendment 3 and Post-Amendment 3):
The secondary objectives are to evaluate the pharmacokinetics, pharmacodynamics, safety, and 
skin tolerability of oxybutynin chloride gel in pediatric patients.


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Study Design:
This study was initiated as a double-blind, placebo-controlled study with an open-label 
extension, and amended to enroll patients under only open-label treatment. Prior to Amendment 
3, patients aged 6 years to < 17 years were randomly assigned 1:1 to receive double-blind 
oxybutynin chloride gel or placebo gel for 6 weeks, followed by an open-label, 8-week period to 
generate safety data. All patients began treatment with 0.75 g of gel/day for 2 weeks. Patients 
then returned to the clinic for a potential dose titration and at this time their dose could have been 
adjusted up to 1 g/day, down to 0.5 g/day, or remained the same at 0.75 g/day. The determination 
of dose was based on the investigator’s clinical judgment and assessment of the patient’s bladder 
symptoms and treatment side effects. Dose titration was permitted only once during the entire 
6-week double-blind, placebo-controlled period. Patients continued blinded treatment for 
4 additional weeks until the end of the double-blind treatment period.
Post-Amendment 3, the study dose-titration study in pediatric patients, ages 3 years to 
< 17 years, with detrusor overactivity associated with a neurological condition. Efforts will be 
made to enroll a greater number of patients from the ages of 3 years to < 6 years. Patients must 
be suitable candidates for anticholinergic therapy and must be using clean intermittent 
catheterization (CIC) for bladder control. The study will include a screening period from Day -13 
to Day -5 and a 14-week open-label treatment period. The expected duration of the study for 
each patient will be up to 16 weeks. No changes were made in the starting dose, compared to the 
Pre-Amendment 3 study design, in that all patients will begin treatment with 0.75 g of gel/day 
for 2 weeks. Patients will then return to the clinic for a potential dose titration and at this time 
their dose may be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day, 
depending on individual response and tolerability. The determination of dose will be based on the 
investigator’s clinical judgment and assessment of the patient’s bladder symptoms and treatment 
side effects. Dose titration will be permitted only once during the entire 14-week treatment 
period. Patients will continue the adjusted dose for 12 additional weeks until the end of the 
open-label treatment period.
Safety will be evaluated by monitoring adverse events, physical examinations, vital signs, 
clinical laboratory evaluations, skin erythema at the application site, and a vision symptom 
questionnaire.
Study Population:
Pre-Amendment 3 included pediatric patients, from ages 6 years to < 17 years, who had a 
diagnosis of detrusor overactivity associated with a neurological condition and were using CIC 
to control bladder function. These patients were enrolled into the 6-week placebo-controlled 
treatment plus an 8-week open-label treatment phase of the study. Post‑Amendment 3 enrollment 
will include pediatric patients from ages 3 years to < 17 years, who have a diagnosis of detrusor 
overactivity associated with a neurological condition and are using CIC to control bladder 
function, with an enrollment of a minimum of 25 patients. These patients will be enrolled in a 
14-week open-label treatment phase (approximately 10 patients are expected to complete the 
14 weeks).
Test Product, Dose, and Mode of Administration:
Oxybutynin chloride gel, 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g 
sachets, applied transdermally once daily to dry intact skin.






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3
TABLE OF CONTENTS
1
TITLE PAGE .......................................................................................................................1
Protocol Amendment Summary of Changes ................................................................................3
2
SYNOPSIS ..........................................................................................................................9
3
TABLE OF CONTENTS....................................................................................................13
4
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS........................................17
5
ETHICS.............................................................................................................................18
5.1
Institutional Review Board or Ethics Committee.......................................................18
5.2
Ethical Conduct of Study ..........................................................................................18
5.3
Patient Information and Consent ...............................................................................18
5.4
Authorization to Disclose Protected Health Information............................................19
6
INVESTIGATOR AND STUDY ADMINISTRATIVE STRUCTURE ...............................20
7
INTRODUCTION .............................................................................................................21
8
STUDY OBJECTIVES ......................................................................................................23
8.1
Primary Objectives....................................................................................................23
8.2
Secondary Objectives................................................................................................23
9
INVESTIGATIONAL PLAN .............................................................................................24
9.1
Overall Study Design and Plan..................................................................................24
9.2
Rationale for Study Design and Control Group .........................................................25
9.3
Selection of Study Population ...................................................................................26
9.3.1
Inclusion Criteria...........................................................................................26
9.3.2
Exclusion Criteria..........................................................................................27
9.3.3
Patient Identification .....................................................................................28
9.3.4
Removal of Patients from Treatment or Assessment......................................28
9.4
Study Treatments ......................................................................................................28
9.4.1
Treatments Administered...............................................................................28
9.4.2
Identity of Study Treatment ...........................................................................29
9.4.2.1
Description of Study Treatment ......................................................29
9.4.2.2
Packaging, Labeling, and Dispensing ..............................................29
9.4.2.3
Storage and Accountability..............................................................29
9.4.3
Method of Assigning Patients to Treatment Groups.......................................30
9.4.4
Selection of Doses and Timing of Administration in the Study.......................30
9.4.5
Blinding ........................................................................................................31
9.4.6
Prior and Concomitant Therapy.....................................................................31
9.4.7
Treatment Compliance...................................................................................32


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9.5
Study Activities.........................................................................................................32
9.5.1
Screening Period (5 to 13 Days) ....................................................................32
9.5.1.1
Visit A (Screening Visit)..................................................................32
9.5.2
Open-label Treatment Period (14 Weeks) ......................................................33
9.5.2.1
Visit B (Baseline Visit) (Week 0 of Treatment)................................33
9.5.2.2
Visit C (Week 2 of Treatment) Dose Titration Opportunity ..............34
9.5.2.3
Visit D (Week 6 of Treatment).........................................................34
9.5.2.4
Visit E (Week 10 of Treatment).......................................................35
9.5.2.5
Visit F (Week 14 of Treatment) or Early Termination ......................35
9.5.3
Exit/Early Termination Visit ..........................................................................36
9.5.4
Early Termination Activities ..........................................................................36
9.6
Efficacy Assessment .................................................................................................36
9.6.1
Urinary Diary................................................................................................36
9.6.2
Efficacy Variables..........................................................................................36
9.6.2.1
Primary Efficacy Variable................................................................36
9.6.2.2
Secondary Efficacy Variables ..........................................................37
9.6.2.3
Urodynamic Variables .....................................................................37
9.7
Safety Variables ........................................................................................................37
9.7.1
Adverse Events..............................................................................................38
9.7.1.1
Causality Assessment......................................................................38
9.7.1.2
Severity Assessment........................................................................39
9.7.1.3
Serious Adverse Event ....................................................................39
9.7.1.4
Reporting Adverse Events and Serious Adverse Events..................40
9.7.1.5
Immediate Reporting of Serious Adverse Events and Events of 
Special Interest...............................................................................41
9.7.1.6
Reporting of Pregnancies Occurring During the Study .................41
9.7.1.7
Potential Hy’s Law Cases...............................................................42
9.7.2
Clinical Laboratory Evaluations ....................................................................43
9.7.3
Application Site Erythema Assessment..........................................................44
9.7.4
Physical Examination ....................................................................................44
9.7.5
Vital Signs.....................................................................................................44
9.8
Other Assessments ....................................................................................................44
9.8.1
Determination of R- and S- Oxybutynin and N-desethyloxybutynin Plasma 
Concentrations ..............................................................................................44
9.8.2
Medical History.............................................................................................45
9.8.3
Electrocardiograms........................................................................................45
9.8.4
Concomitant Medication Use ........................................................................45
9.8.5
Anticholinergic Symptoms Questionnaire......................................................45


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9.8.6
Vision Symptom Questionnaire ....................................................................45
9.9
Appropriateness of Measurements.............................................................................46
10 QUALITY CONTROL AND ASSURANCE......................................................................47
11
PLANNED STATISTICAL METHODS.............................................................................48
11.1 Determination of Sample Size...................................................................................48
11.2 Analysis Populations and Databases..........................................................................48
11.3 Efficacy Parameters ..................................................................................................50
11.4 Descriptive Summaries of Efficacy Parameters .........................................................50
11.5 Statistical Analyses of Efficacy Parameters...............................................................51
11.5.1 Statistical Analysis of the Primary Efficacy Endpoint ....................................51
11.5.2 Statistical Analysis of the Secondary Efficacy Endpoints...............................51
11.5.3 Additional Analyses ......................................................................................51
11.5.4 Subgroup Analyses........................................................................................52
11.6 Safety Analysis .........................................................................................................52
11.6.1 Adverse Events..............................................................................................52
11.6.2 Extent of Exposure........................................................................................53
11.6.3 Laboratory Evaluations and Abnormalities ....................................................53
11.6.4 Vital Signs.....................................................................................................54
11.6.5 Physical Examinations...................................................................................54
11.6.6 Skin Assessments for Erythema.....................................................................54
11.7 Other Assessments ....................................................................................................54
11.7.1 Demographic and Other Pretreatment Characteristics ....................................54
11.7.2 Medications...................................................................................................54
11.7.3 Compliance ...................................................................................................55
11.7.4 Urodynamic Variables ...................................................................................55
11.7.5 Anticholinergic Symptoms Questionnaire ....................................................55
11.7.6 Vision Symptom Questionnaire ....................................................................56
11.7.7 R- and S-Oxybutynin and N-desethyloxybutynin Plasma Concentrations ......56
12 DATA HANDLING AND RECORDKEEPING .................................................................57
12.1 Data Generation and Analysis ...................................................................................57
12.2 Access to Source Documentation ..............................................................................57
12.3 Retention of Data......................................................................................................57
13 OTHER INFORMATION ..................................................................................................58
13.1 Financing and Insurance............................................................................................58
13.2 Publication and Disclosure Policy.............................................................................58
13.3 Termination of the Study...........................................................................................58


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14 REFERENCE LIST ...........................................................................................................59
15 APPENDICES ...................................................................................................................60
Appendix 1
Schedule of Events..........................................................................61
Appendix 2
Clinical Laboratory Evaluations ......................................................62
Appendix 3
Sample 2-Day Urinary Diary...........................................................63
Appendix 4
Urodynamic Evaluation...................................................................66
Appendix 5
Anticholinergic Questionnaire.........................................................67
Appendix 6
Vision Symptom Questionnaire for Parent/Caregiver.......................70
Appendix 7
Gel Application Instructions............................................................71
Appendix 8
Vision Assessment Instructions for Site ...........................................73


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4
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
AE
adverse event
ANCOVA
analysis of covariance
CFB
change from baseline
CFR
Code of Federal Regulations
CIC
clean intermittent catheterization
DDAVP
desmopressin
DEO
N-desethyloxybutynin
EC
ethics committee
ECG
electrocardiogram
eCRF
electronic case report form
ET
early termination
FDA
Food and Drug Administration
GCP
good clinical practice
HEENT
head, ears, eyes, nose, throat
HIPAA
Health Insurance Portability and Accountability Act
ICF
informed consent form
ICH
International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use
ID
identification
IND
investigational new drug application
IRB
institutional review board
ITT
intent-to-treat
IVRS
interactive voice response system
LOCF
last observation carried forward
MedDRA
Medical Dictionary for Regulatory Activities
NF
National Formulary
OC
observed cases
PHI
protected health information
PK
pharmacokinetic
PP
per protocol
SAE
serious adverse event
TDS
transdermal system
ULN
upper limit of the normal range
USP
United States Pharmacopeia


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5
ETHICS
5.1
Institutional Review Board or Ethics Committee
The protocol and supporting documents for this study will be reviewed and approved by an 
appropriately constituted institutional review board (IRB) or ethics committee (EC) prior to 
study initiation.
All reviews and approvals will be in accordance with GCP as contained in the ICH guidelines 
(E6) and US CFR governing IRBs (Title 21, Part 56).
A letter from the IRB or EC documenting approval of the investigator (who must be identified by 
name), the protocol (must be identified by title), and the patient consent form must be received 
by the sponsor or its designee prior to study initiation. A progress report will be submitted by the 
investigator to the IRB or EC at intervals specified by the IRB or EC, but not less than annually. 
A copy of this progress report will be sent to the sponsor. After completion of the study, the 
investigator will submit a signed clinical safety summary of the study to the IRB or EC.
5.2
Ethical Conduct of Study
The study will be conducted in accordance with GCP as contained in ICH guidelines and US 
CFR governing the protection of human patients (Title 21, Part 50) and the obligations of clinical 
investigators (Title 21, Part 312.60 through 312.69). The study will also be conducted in 
accordance with the World Medical Association Declaration of Helsinki and all amendments.
The sponsor is responsible for the ongoing safety evaluation of the study treatment and will 
expedite the notification of all participating investigators and regulatory authorities of findings 
that are both serious and unexpected and/or that could adversely affect the safety of patients or 
the conduct of the study, or alter an IRB’s or EC’s approval to continue the study.
5.3
Patient Information and Consent
The investigator will ensure that each patient will provide assent (if applicable and according to 
IRB regulations) and their parent(s) or legal guardian(s) will sign the written informed consent 
form in accordance with applicable regulations.
Patients and their parent(s) or legal guardian(s) will be interviewed at the initial Screening Visit 
by qualified staff at the site and will be provided with a full description of the nature and purpose 
of the study. The patients and their parent(s) or legal guardian(s) will be given adequate time to 
consider the risks associated with participation in the study. Each patient will provide assent (if 
applicable and according to IRB regulations), and their parent(s) or legal guardian(s) will provide 
written informed consent prior to participating in any study procedures. The original signed 
consent forms will be retained on file at the clinical sites and a copy will be given to the patient. 
Case histories (patient charts) will also document that informed consent was obtained prior to the 
patient’s participation in the study.


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5.4
Authorization to Disclose Protected Health Information
If required under HIPAA regulations, patients and their parent(s) or legal guardian(s) will be 
informed of the following information:

The sponsor of the study

Any contractors that may be involved in the study

The purpose of the protected health information (PHI) being collected

The possibility that the PHI may be re-disclosed

The duration of the authorization

The patient’s and parent’s or legal guardian’s rights to revoke the authorization; and

The right of the patient and parent(s) or legal guardian(s) to refuse signature and limit 
access to PHI during the conduct of the trial (US CFR Title 45, Parts 160 and 164)
Authorization to disclose PHI must be obtained before the patient enters the study.




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7
INTRODUCTION
Oxybutynin chloride is a well-known anticholinergic and antispasmodic agent that has gained 
widespread use in the pharmacological management of overactive bladder over the past 
3 decades. It has shown efficacy, safety, and tolerability in the treatment of both adult and 
pediatric patients. Oxybutynin is currently available for use in adults as immediate- and 
extended-release oral formulations, syrup, transdermal delivery systems (TDS), and as 
oxybutynin chloride gel (Gelnique®).
Oxybutynin chloride gel is formulated as a clear, colorless hydroalcoholic gel, available in a 
1 gram unit dose that contains 100 mg oxybutynin chloride. This topical formulation was 
designed to provide the convenience of a once-a-day dosage form with decreased anticholinergic 
side effects compared to oral oxybutynin products and improved skin tolerability relative to the 
oxybutynin TDS (Oxytrol®).
Phase 1 investigations evaluating the pharmacokinetics and metabolism of oxybutynin chloride 
gel demonstrated that the gel provided sustained systemic delivery of therapeutic levels of 
oxybutynin.1 In a pharmacokinetic (PK) study in adults, application of 1 g of oxybutynin 
chloride gel produced comparable oxybutynin absorption and plasma concentration profiles to 
3.9 mg/day of Oxytrol transdermal administration.1 The application of oxybutynin chloride gel
to different anatomical sites (abdomen, thighs, and upper arms/shoulders) resulted in similar 
oxybutynin absorption from all of the sites.2
A Phase 3 study showed that oxybutynin chloride gel was effective in treating the symptoms of 
overactive bladder in adults and results from the same study indicated that the gel was safe and 
well tolerated, with improved skin tolerability over oxybutynin transdermal systems.3
Neurogenic bladder is a condition characterized by overactivity of both the detrusor and 
sphincter muscles resulting in incontinence, urinary retention, and bladder infections. The vast 
majority of neurogenic bladder dysfunction in the pediatric population is the result of a 
myelomeningocele.4 When not treated adequately this condition will eventually impact the health 
of the kidneys.4 Available data demonstrate that pediatric patients with detrusor overactivity 
associated with a neurological condition may benefit from improved bladder control with 
anticholinergic treatment.5,6
This Phase 4 study is being undertaken to provide information on the safety and efficacy of 
oxybutynin chloride gel in pediatric patients with neurogenic bladder dysfunction. In a 
previously conducted Phase 4 clinical study, children with neurogenic bladder were treated with 
oxybutynin TDS.7 This study demonstrated that treatment with either 2.6 mg/day or 3.9 mg/day 
oxybutynin TDS improved the symptoms of detrusor overactivity and the urodynamic 
paratmers.7 Oxybutynin and N-desethyloxybutynin (DEO) metabolite plasma concentrations in 
these pediatric patients did not differ significantly from those observed in adults administered 
Oxytrol (3.9 mg/day), suggesting comparable oxybutynin chloride bioavailability and 
metabolism in adults and children.7 Therefore, the proposed doses of 0.5 g, 0.75 g, and 1 g 
oxybutynin chloride gel are in the range of oxybutynin TDS doses previously evaluated and 
shown to be safe and effective in this pediatric population.


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The current standard of treatment is a combination of clean intermittent catheterization (CIC) 
and an anticholinergic agent, such as oxybutynin.6 This combination has shown statistically 
significant and clinically meaningful changes from baseline in catheterization urine volume, as 
well as improvements in the percentage of catheterizations without leakage and in key 
urodynamic parameters.8 These same clinical and urodynamic parameters will be used in the 
present study to evaluate the safety and efficacy of oxybutynin chloride gel when administered 
to pediatric patients.


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8
STUDY OBJECTIVES
8.1
Primary Objectives
The primary objectives of this study are:

Pre-amendment 3: To evaluate the efficacy of daily treatment with oxybutynin chloride gel 
compared to placebo in pediatric patients during the first 6 weeks of a 14-week treatment 
period.

Post-amendment 3: To evaluate the efficacy of daily treatment with oxybutynin chloride gel 
in pediatric patients during the first 6-weeks of a 14-week open-label treatment period.
8.2
Secondary Objectives
The secondary objectives of this study are to evaluate the pharmacokinetics, pharmacodynamics, 
safety, and skin tolerability of oxybutynin chloride gel in pediatric patients.


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9
INVESTIGATIONAL PLAN
9.1
Overall Study Design and Plan
This study was initiated as a double-blind, placebo-controlled study with an open-label 
extension, and is now amended to continuing to enroll patients under only open-label 
treatment.
Pre-Amendment 3, patients ages 6 to >17 years, were randomly assigned 1:1 to receive double-
blind oxybutynin chloride gel or placebo gel for 6 weeks, followed by an open-label, 8-week 
period to generate safety data. All patients began treatment with 0.75 g of gel/day for 2 weeks. 
Patients then returned to the clinic for a potential dose titration and at this time their dose 
could have been adjusted up to 1 g/day, down to 0.5 g/day, or remained the same at 0.75 g/day. 
The determination of dose was based on the investigator’s clinical judgment and assessment of 
the patient’s bladder symptoms and treatment side effects.
Dose titration was permitted only once during the entire 6-week double-blind, placebo-
controlled period. Patients continued blinded treatment for 4 additional weeks until the end of 
the double-blind treatment period. Pre-Amendment 3, visits were identified numerically 
(ie, Visit 1 through Visit 8/Early Termination).
Post-Amendment 3, this study will continue as an open-label study for new patients enrolled 
under the present protocol (Amendment 3), with a similar patient population (ie, pediatric 
patients who have been diagnosed with detrusor overactivity that is associated with a 
neurogenic condition) and will also enroll younger patients (minimum age of 3 years).
For patients enrolled under Post-Amendment 3, this will be a multicenter, open-label, dose-
titration study in pediatric patients, ages 3 years to < 17 years, who have been diagnosed with 
detrusor overactivity that is associated with a neurogenic condition. Patients must be suitable 
candidates for anticholinergic therapy and must be using CIC for bladder control. No changes 
were made in the starting dose, compared to the Pre-Amendment 3 study design, in that all 
patients will begin treatment with 0.75 g of gel/day for 2 weeks. Patients will then return to the 
clinic for a potential dose titration and at this time their dose may be adjusted up to 1 g/day, 
down to 0.5 g/day, or remain the same at 0.75 g/day, depending on individual response and 
tolerability. The determination of dose will be based on the investigator’s clinical judgment 
and assessment of the patient’s bladder symptoms and treatment side effects. Dose titration 
will be permitted only once during the entire 14-week treatment period. Patients will continue 
the adjusted dose for 12 additional weeks until the end of the open-label treatment period. 
Post-Amendment 3, visits will be identified alphabetically (ie, Visit A through Visit F/ET).
In the Post-Amendment 3 study design (open-label treatment only), the study will consist of a 
screening period from Day -13 to Day -5 and a 14 week open-label treatment period. The total 
study duration for each patient will be approximately 16 weeks.
The screening period will include 1 clinic visit; Visit A (Screening Visit), where patients will be 
considered for inclusion in the study. Following Visit A, all patients taking anticholinergic 
medications will be asked to discontinue treatment and complete a 3-day washout period (11-day 
washout period if the patient was previously taking solifenacin). In addition, patients will be 






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9.3.2 Exclusion Criteria
Patient will be excluded from participation if they meet any of the following criteria:
EX01. Are pregnant or lactating
EX02. Have a patient-reported average CIC of more than 6 times per 24-hour period during the 
screening period, as captured by the 2-day urinary diary
EX03. Have 1 or more treatable conditions, other than neurogenic bladder dysfunction, that may 
cause urinary incontinence or urgency (eg, urinary tract infection or requirement for acute 
to intermittent use of diuretics)
Note: Patients with evidence of acute urinary tract infection may receive treatment and 
then be re-evaluated for entry into the study. Asymptomatic bacteriuria, which can be
associated with CIC, is not an exclusionary condition.
EX04. Have any medical condition that precludes their safe participation in the study or may 
confound the outcome of the study (eg, history of lower urinary tract surgery within 6 
months of screening, > 2 urinary tract infections within 6 months of screening, unstable 
diabetes mellitus; hydronephrosis unrelated to neurogenic bladder, or reflux Grade 4 or 5)
EX05. Have ECG with clinically significant abnormal results
EX06. Have had surgical bladder augmentation (eg, use of ileum or colon to provide surgical 
expansion of bladder capacity, gastrocystoplasty, detrusor myotomy) within 1 year of 
screening
EX07. Have any anatomical abnormalities of the urinary tract system that can affect bladder 
function
EX08. Have an active skin disorder, such as eczema, seborrhea, or psoriasis affecting the gel 
application areas
EX09. Have a known hypersensitivity or other contraindication to anticholinergic medications 
EX10. Require treatment with medications that may interfere with the metabolism of 
oxybutynin, including antimycotic agents (eg, ketoconazole, itraconazole, miconazole), 
macrolide antibiotics (eg, erythromycin, clarithromycin), other anticholinergic agents 
(eg, oxybutynin, propantheline, dicyclomine, flavoxate, hyoscyamine, tolterodine, 
darifenacin), or desmopressin (DDAVP) or require concomitant medications that may 
affect detrusor activity, including tricyclic antidepressants (eg, imipramine, doxepin, 
desipramine, nortriptyline, trimipramine, clomipramine, protriptyline)
Note: Patients who are taking excluded medications prior to starting the study can 
participate in the study only if the excluded medications can be safety discontinued at 
least 3 days before the initiation of the urinary diary. Patients who are taking solifenacin 
(Vesicare®) should discontinue treatment at least 11 days prior to the initiation of the 
urinary diary.
EX11. Have participated in another investigational drug study within 30 days prior to the 
Baseline Visit


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EX12. Have been diagnosed with asymmetric/unequal or severe refractive error in either eye 
prior to the Baseline Visit. If a patient < 8 years old has known risk factors for eye 
disease before starting treatment (ie, family history of pediatric eye disease and/or 
symptoms of a vision disorder) it will be recommended, at the discretion of the 
investigator, that a comprehensive eye examination is performed by a pediatric 
ophthalmologist prior to enrollment.
9.3.3 Patient Identification
Patient study identification numbers will be assigned at the Screening Visit. Patient numbers will 
be consecutive at each study site beginning with 001. Patient numbers will consist of the site 
number (3 digits) followed by the patient number (3 digits) at that site. Patient identification 
numbers will be used throughout the trial.
9.3.4 Removal of Patients from Treatment or Assessment
An attempt will be made to identify and follow every patient enrolled in the study through to 
completion. If a patient withdraws, or is withdrawn from the study by the investigator, the reason 
and circumstances for such early termination must be fully documented.
Patients may be withdrawn from treatment for the occurrence of a serious adverse event (SAE) 
or any other condition that may create a safety risk. The sponsor must be informed within 48 
hours if any patient withdraws from the study regardless of cause. Patients who are withdrawn 
from the study may not be re-enrolled.
9.4
Study Treatments
9.4.1 Treatments Administered
Pre-Amendment 3, patients were randomized to receive oxybutynin chloride gel or placebo 
during the 6-week double-blind treatment period, and all patients received oxybutynin chloride 
gel during the 8-week open-label treatment period. Patients randomized to double- blind 
oxybutynin chloride gel started treatment at 0.75 g/day, and the dose may have been adjusted 
after 2 weeks of treatment to a higher or lower dose (0.5 g/day or 1 g/day) based on the 
investigator’s clinical judgment and assessment of bladder symptoms and treatment side 
effects. All patients who entered the open-label safety period were started on 0.75 g/day 
oxybutynin chloride gel, and the dose may have been adjusted after 2 weeks of treatment as 
described for the double-blind treatment period.
Post-Amendment 3, no changes were made in the starting dose, compared to the 
Pre-Amendment 3 study design, in that all patients will begin treatment with 0.75 g of gel/day 
for 2 weeks. Patients will then return to the clinic for a potential dose titration and at this time 
their dose may be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day, 
depending on individual response and tolerability. The determination of dose will be based on 
the investigator’s clinical judgment and assessment of the patient’s bladder symptoms and 
treatment side effects. Dose titration will be permitted only once during the entire 14-week 
treatment period. Patients will continue the adjusted dose for 12 additional weeks until the end 
of the open-label treatment period.


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Patients or parents/caregiver will apply the gel each morning to rotating application sites on the 
abdomen, upper arms/shoulders, and thighs. The person who applies the gel should wash his or 
her hands immediately after application with soap and water.
Patients should not bathe or shower sooner than 1 hour following a gel application. In the event 
of direct contact between unwashed or unclothed skin to which gel has been applied and the skin 
of another person, the contact area on the other person should be washed with soap and water as 
soon as possible.
9.4.2 Identity of Study Treatment
9.4.2.1
Description of Study Treatment
Oxybutynin chloride gel is a pH 6.0 clear, colorless, hydroalcoholic gel containing 100 mg of 
oxybutynin hydrochloride salt per gram of gel. Each gram is designed to deliver approximately 
4 mg oxybutynin to the systemic circulation. Inactive ingredients are alcohol, USP; glycerin, 
USP; hydroxypropyl cellulose, NF; sodium hydroxide, NF; and purified water, USP. The 0.5 g, 
0.75 g, and 1 g doses are of identical composition and differ only in the amount of gel applied.
The study treatment is manufactured in accordance with current Good Manufacturing Practice 
and will be distributed to study centers by the sponsor.
9.4.2.2
Packaging, Labeling, and Dispensing
The study treatment will be packaged in individual patient cartons containing a sufficient supply 
of sachets for the completion of the treatment period, plus an additional amount for supplies that 
are mishandled. Each patient carton will be color-coded by dose level (0.5, 0.75, or 1 g). The 
gel will be supplied as individually pouched 0.5 g, 0.75 g, and 1 g dose sachets of the active gel. 
Each sachet will be labeled with the protocol number, study treatment identification (ID), 
contents, caution statement (Caution: New Drug – Limited by Federal Law to Investigational 
Use) and the sponsor’s name and address. These labeled sachets will be packaged in visit cartons 
to be dispensed to patients at their clinic visits. Two-part labels will be attached to each visit 
carton: one part will remain on the container and one will be detached when the container is 
dispensed to the study patient. The carton will be labeled with the protocol number, medication 
ID, contents, caution statement, the sponsor’s name and address, and directions to apply 
contents of 1 sachet daily as directed. Immediately before dispensing the study treatment, the 
Investigator will write the patient’s 6-digit identification number, patient’s initials, and date 
dispensed on the label. The detachable portion will contain the dosing information for each 
patient (ie, the starting dose of 0.75 g/day, or a later modified dose level of 0.5 or 1 g/day). 
Dosing information will be recorded on the electronic case report form (eCRF).
9.4.2.3
Storage and Accountability
The study treatment will be stored in a secure location at controlled room temperature, 20°C to 
25°C/68° to 77°F (with excursions allowed between 15°C and 30°C/59°F and 86°F) and away 
from direct sunlight.
The investigator shall maintain accurate study treatment inventory records, including the 
quantities and date of receipt of supplies from the sponsor, and the quantities and dates of 
dispensing to study participants. All study treatment supplies must be accounted for at study 


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termination and a written explanation provided for any discrepancies. All unused supplies shall 
be returned to the sponsor or, if authorized in writing by the sponsor, destroyed properly at the 
study site. Shipping and handling of all study treatment will conform to FDA regulations for 
investigational drug products.
Reasons for departure from the expected dispensing regimen will also be recorded. At 
completion of the study, to satisfy regulatory requirements regarding drug accountability, all 
study treatment supplies will be stored, inventoried, reconciled, and destroyed or returned to the 
sponsor according to applicable state and federal regulations. A written explanation must be 
provided for any discrepancies. The study monitor must review all records of investigational 
supplies prior to the return or destruction of any study treatment.
9.4.3 Method of Assigning Patients to Treatment Groups
Pre-Amendment 3, patients were randomized to oxybutynin chloride gel or placebo treatment in 
a 1:1 ratio within each stratification level, using an interactive voice recognition system (IVRS). 
Enrollment was stratified based on sex, age, and weight. Stratification was done within the 
following groups: male and female; 6 to < 12 years-of-age and 12 to < 17 years-of-age; and 
≤25.0 kg and > 25.0 kg for the 6 to < 12 years-of-age group and ≤ 50.0 kg and > 50.0 kg for the 
12 to < 17 years-of age group.
Post-Amendment 3, no changes were made in the starting dose, compared to the Pre-
Amendment 3 study design, in that all patients will begin treatment with 0.75 g of gel/day for 
2 weeks. Patients will then return to the clinic for a potential dose titration and at this time 
their dose may be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day, 
depending on individual response and tolerability. All patients will be assigned to oxybutynin 
chloride gel; patient enrollment will not be stratified.
9.4.4 Selection of Doses and Timing of Administration in the Study
Pre-Amendment 3, patients were randomized to receive oxybutynin chloride gel or placebo 
during the 6-week double-blind treatment period, and all patients received oxybutynin chloride 
gel during the 8-week open-label treatment period. Patients randomized to double-blind 
oxybutynin chloride gel started treatment at 0.75 g/day, and the dose may have been adjusted 
after 2 weeks of treatment to a higher or lower dose (0.5 g/day or 1 g/day) based on the 
investigator’s clinical judgment and assessment of bladder symptoms and treatment side 
effects. All patients who entered the open-label safety period were started on 0.75 g/day 
oxybutynin chloride gel, and the dose may have been adjusted after 2 weeks of treatment as
described for the double-blind treatment period.
Post-Amendment 3, no changes were made in the starting dose, compared to the 
Pre-Amendment 3 study design, in that all patients will begin treatment with 0.75 g of gel/day 
for 2 weeks. Patients will then return to the clinic for a potential dose titration and at this time 
their dose may be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day, 
depending on individual response and tolerability. The determination of dose will be based on 
the investigator’s clinical judgment and assessment of the patient’s bladder symptoms and 
treatment side effects. Dose titration will be permitted only once during the entire 14-week 




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9.4.7 Treatment Compliance
Compliance with the assigned study treatment regimen will be assessed by comparing the 
number of sachets expected to be used as based on the total number of treatment days with the 
actual number used (expressed as percentage of use/expected). Compliance will be assessed and 
recorded at each clinic visit and for the overall study.
9.5
Study Activities
The following sections (Sections 9.5.1 to 9.5.4) provide details of the study activities 
Post-Amendment 3 (ie, only open-label enrollment). Note that alterations from prior details 
are shown in bold italics and are further enumerated in the accompanying Summary of 
Changes document. A schedule of events table is presented in Section 15, Appendix 1.
9.5.1 Screening Period (5 to 13 Days)
The screening period will occur from Day -13 to Day -5 and will include 1 clinic visit, Visit A
(Screening Visit), where patients will be considered for inclusion in the study. Following Visit A, 
all patients taking anticholinergic medications will be asked to complete a 3-day minimum 
washout period (11-day washout period if the patient was previously taking solifenacin). 
Following the washout period, patients (or parents/caregivers) will complete a 2-day urinary 
diary on 2 consecutive days, prior to Visit B. To minimize off-treatment time, patients may 
complete the washout period and urinary diary as close to Visit B as possible. All evaluations and 
procedures that will be conducted during the screening period are listed below in Section 9.5.1.1.
9.5.1.1
Visit A (Screening Visit)
Site personnel will perform the following:
1.
Provide detailed explanation of the study.
2.
Obtain informed consent and assent (if applicable)
3.
Vision screening assessment. Prior to Baseline Visit patients who are < 8 years of age 
at the time of screening who have not had a vision examination in the last 12 months 
prior to screening are required to have a vision assessment prior to or at the baseline 
visit. The vision assessment can be performed at the study site or a separate site by a 
healthcare professional [nurse, technician, or physician] with the appropriate 
training.
4.
Assign 6 –digit identification number using IVRS
The following evaluations must be completed before Visit B (Baseline Visit):
5.
Review and document pertinent inclusion and exclusion criteria.
6.
Record demographic information (sex, race, ethnicity, and date of birth).
7.
Obtain medical history, including a history of the patient’s incontinence.
8.
Obtain prior and current medication use information.
9.
Measure and record height and weight.
10. Measure and record vital signs (blood pressure, heart rate, respiratory rate, and 
temperature).
11. Record output of 12-lead electrocardiogram.


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12. Conduct physical examination, which will include a review of the following: body as a 
whole; skin; head, ears, eyes, nose, throat (HEENT); cardiovascular; respiratory; 
musculoskeletal; neurologic; lymphatic/thyroid; and abdomen.
13. Collect blood and urine samples for laboratory evaluation, including urinalysis and urine 
culture (Appendix 2).
14. Collect urine sample for pregnancy test for all females of childbearing potential 
(Appendix 2).
15. Instruct patients to complete a 3-day minimum washout period, if patients are presently 
on anticholinergic or other excluded medication (11-day washout period if the patient 
was previously taking solifenacin).
16. Dispense 2-day urinary diary and review instructions for its completion (Appendix 3). 
Remind patients/caregivers that the urinary diary must be completed following the 
washout period, but prior to scheduled Visit B. The patient/caregiver should not be 
informed of the minimum diary requirements for eligibility.
17. Patients < 8 years old who have not had a vision examination in the last 12 months 
prior to screening will require a vision screening assessment prior to or at the 
Baseline Visit (Appendix 8). The vision assessment can be performed at the study site 
or a separate site by a healthcare professional (nurse, technician, or physician) with 
the appropriate training.
9.5.2 Open-label Treatment Period (14 Weeks)
The 14-week, open-label treatment period will begin at Visit B (Baseline Visit, Week 0 of 
treatment). Patients should have completed the washout period and the 2-day urinary diary prior 
to Visit B. If patients continue to meet eligibility criteria at Visit B, a urodynamic evaluation will 
be conducted. All patients will apply 0.75 g of gel daily to rotating sites located on the abdomen, 
upper arms/shoulders, or thighs. If patients are not able to apply the study treatment, their 
caregivers should perform this task on a daily basis.
9.5.2.1
Visit B (Baseline Visit) (Week 0 of Treatment)
Site personnel will perform the following activities at Visit B:
1.
Collect and review 2-day urinary diary and data.
Patients who accurately complete the 2-day urinary diary but do not meet entry criteria 
based on number of catheterizations will not undergo further evaluation procedures. 
Patients who fail to accurately complete the urinary diary may be allowed to repeat the 
diary evaluation at the discretion of the investigator. Patients who then meet the criteria 
will be allowed to complete Visit B evaluation procedures. Patients failing to qualify for 
the study after the second diary attempt will be withdrawn from further study 
participation.
2.
Update medical history and current medication use.
3.
Review and document pertinent inclusion and exclusion criteria.
4.
Measure vital signs (blood pressure, heart rate, respiratory rate and temperature).
5.
Collect urine sample for urinalysis (use on site dipstick to determine presence of 
infection).
6.
Perform urodynamic evaluations (Appendix 4).
7.
Instruct patient/caregiver to complete the anticholinergic questionnaire (Appendix 5) 
and vision symptom questionnaire (Appendix 6).


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8.
Dispense study treatment kit (dose of 0.75 g/day), if the inclusion/exclusion criteria are 
met.
9.
Instruct patient/caregiver on study treatment application (Appendix 7) and supervise 
application of first dose.
10. Patients < 8 years old who have not had a vision examination in the last 12 months 
prior to screening will be required to have a vision screening test prior to or at the 
Baseline Visit (Appendix 8). The vision assessment can be performed at the study site 
or a separate site by a healthcare professional (nurse, technician, or physician) with 
the appropriate training.
9.5.2.2
Visit C (Week 2 of Treatment) Dose Titration Opportunity
Patients will return to the clinic after 2 weeks of treatment for evaluation and a dose titration 
opportunity. Site personnel will perform the following activities:
1.
Perform study treatment accountability.
2.
Record concomitant medication use.
3.
Measure and record vital signs (blood pressure, heart rate, respiratory rate, and 
temperature).
4.
Query for adverse events.
5.
Assess erythema/application site adverse events at most recent application site and
document findings.
6.
Dose titration: Based on the investigator’s clinical judgment and assessment of bladder 
symptoms and treatment side effects, the dose can remain the same at 0.75 g/day, be 
increased to 1 g/day, or can be reduced to 0.5 g/day.
7.
Collect blood sample for PK analysis and record the date and time of collection. Record 
date and time of last 2 days gel applications (visit date and day prior).
8.
Dispense study treatment kit for the next 4 weeks of treatment and instruct 
patient/caregiver on study treatment application (Appendix 7).
9.
Dispense 2-day urinary diary and remind patients that the urinary diary must be 
completed in the week prior to Visit D.
10. Instruct patient/caregiver to complete the anticholinergic questionnaire (Appendix 5) 
and the vision symptom questionnaire (Appendix 6).
9.5.2.3
Visit D (Week 6 of Treatment)
Site personnel will perform the following activities at Visit D:
1.
Perform study treatment accountability.
2.
Collect and review 2-day urinary diary and data.
3.
Record concomitant medication use.
4.
Measure and record vital signs (blood pressure, heart rate, respiratory rate, and 
temperature).
5.
Query for adverse events.
6.
Assess erythema/application site adverse events at the most recent application site and 
document findings.


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7.
Instruct patient/caregiver to complete the anticholinergic questionnaire (Appendix 5) 
and vision symptom questionnaire (Appendix 6).
8.
Perform urodynamic evaluations (Appendix 4).
9.
Dispense study treatment kit for the next 4 weeks of treatment.
10. Collect urine sample for pregnancy test for all females of childbearing potential 
(Appendix 2).
11. Collect blood sample for PK analysis and record the date and time of collection.
12. Record date and time of last 2 days of gel applications (visit date and day prior).
9.5.2.4
Visit E (Week 10 of Treatment)
Site personnel will perform the following activities at Visit E:
1.
Perform study treatment accountability.
2.
Record concomitant medication use.
3.
Measure and record vital signs (blood pressure, heart rate, respiratory rate, and 
temperature).
4.
Query for adverse events.
5.
Assess erythema/application site adverse events at the most recent application site and 
document findings.
6.
Instruct patient/caregiver to complete the anticholinergic questionnaire (Appendix 5) 
and vision symptom questionnaire (Appendix 6).
7.
Dispense study treatment kit for the next 4 weeks of treatment.
9.5.2.5
Visit F (Week 14 of Treatment) or Early Termination
Visit F will be the end of the open-label treatment period. Patients will undergo evaluation by 
site personnel who will perform the following activities:
1.
Collect remaining study treatment and perform study treatment accountability.
2.
Record concomitant medication use.
3.
Measure and record vital signs (blood pressure, heart rate, respiratory rate, and 
temperature).
4.
Query for adverse events.
5.
Assess erythema/application site adverse events at the most recent application site and 
document findings.
6.
Instruct patient/caregiver to complete the anticholinergic questionnaire (Appendix 5) 
and the vision symptom questionnaire (Appendix 6).
7.
Conduct physical examination, which will include a review of the following: body as a 
whole, skin, HEENT, cardiovascular, respiratory; musculoskeletal, neurologic, 
lymphatic/thyroid, and abdomen.
8.
Collect blood and urine samples for laboratory evaluation (Appendix 2).
9.
Collect urine sample for pregnancy test for all females of childbearing potential 
(Appendix 2).
10. Collect blood sample for PK analysis and record the date and time of collection.


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9.5.3 Exit/Early Termination Visit
Study site personnel will make every attempt to follow the progress of every patient admitted to 
the study through to study completion. If a patient fails to return for a scheduled visit, a 
reasonable effort should be made to contact the patient and ascertain the reason(s) for not 
returning.
If a patient does not complete the study for any reason (including investigator discretion), the 
reason and circumstances for the patient’s early termination must be fully documented. If 
possible, the assessments specified for the exit visit should be performed.
The sponsor must be informed within 48 hours if any patient withdraws from the study, 
regardless of the cause. Withdrawn patients may not be re-enrolled in the study and will not be 
replaced.
9.5.4 Early Termination Activities
Upon patient withdrawal/early discontinuation from the study, all evaluations scheduled at 
Visit F (Week 14 of treatment) should be completed at the termination visit. If the early 
termination visit occurs immediately after a visit in which a diary had been previously dispensed, 
the diary will be reviewed and collected.
9.6
Efficacy Assessment
The efficacy endpoints of the study will be evaluated based on information derived from the 
2-day urinary diaries and urodynamic assessments recorded at baseline and during the treatment 
period.
9.6.1 Urinary Diary
The urinary diaries will be completed by each patient/caregiver during the week before Visit B 
and Visit D. The 2-day urinary diary will be used to collect information for the parameters listed 
below. A sample urinary diary is provided in Appendix 3.

Number of catheterizations per day

Volume of urine collected at each (after morning awakening) catheterization

Leakage incidents between catheterizations
9.6.2 Efficacy Variables
9.6.2.1
Primary Efficacy Variable
The primary efficacy endpoint is the change from baseline (CFB) to Week 6 of treatment or the 
last observation carried forward (LOCF) in the percentage of catheterizations without a leaking 
accident as recorded in the 2-day urinary diary.


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9.6.2.2
Secondary Efficacy Variables
Secondary endpoints include the CFB to Week 6 of treatment in the following (calculated from 
the 2-day urinary diary data):

Average volume of urine collected per catheterization (for Pre-Amendment 3 population 
only);

Average volume of urine collected at first (morning awakening) catheterization;

Average number of catheterizations per day
9.6.2.3
Urodynamic Variables
Pharmacodynamics will be assessed for treatment under the Pre-Amendment 3 double-blind 
phase, treatment under the Post-Amendment 3 open-label phase, and both groups aggregated 
where appropriate. Pharmacodynamics will be based on urodynamic testing. The following 
parameters will be evaluated:

Maximal bladder capacity

Detrusor pressures at maximum capacity

Maximum amplitude of involuntary detrusor contractions

Volume at first involuntary detrusor contraction

Presence (versus total absence) of involuntary detrusor contractions at > 15 cm H2O
9.7
Safety Variables
Analyses and summaries will be performed for treatment under the Pre-Amendment 3 double-
blind phase, the Pre-Amendment 3 open-label phase, and the Post-Amendment 3 open-label 
phase, with groups aggregated where appropriate.
Patients must be evaluated by a physician or an appropriately trained healthcare professional 
at every visit, and the evaluation must be documented. The procedures discussed below will be 
completed at the designated visits. Safety assessments should not be administered to the patient 
unless the patient is accompanied by his or her consented caregiver.
Safety evaluations will include the following:

Adverse events

Physical examination

Vital signs (blood pressure, heart rate, respiratory rate, and temperature)

Clinical laboratory evaluations including hematology, serum chemistries, and urinalysis

Erythema at the gel application site


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
Vision assessment in children < 8 years old prior to or at the Baseline Visit

Visual assessment by investigator or designee (Appendix 8) and by using a visual 
symptom questionnaire (Appendix 6).
9.7.1 Adverse Events
An AE is any untoward medical occurrence in a patient or clinical investigation patient
administered a pharmaceutical product and which does not necessarily have to have a causal 
relationship with this treatment. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding, for example), symptom, or disease temporally 
associated with the use of a medicinal product, whether or not considered related to the 
medicinal product (ICH-E2A).
For the purpose of the site’s data collection responsibilities, any untoward event that was 
reported from the patient signed the informed consent form (ICF) until 30 days after the final 
protocol-defined study visit or, if the final visit does not occur, the last known dose of study 
treatment is to be considered an AE.
Examples of AEs are as follows:

Changes in the general condition of the patient

Subjective symptoms offered by or elicited from the patient

Objective signs observed by the investigator or other study site personnel

All diseases that occur after signing informed consent, including any change in 
severity or frequency of pre-existing disease

All clinically relevant abnormalities in laboratory values or clinically relevant physical 
findings that occur during the study schedule
Please note that medical procedures scheduled prior to consenting, but occurring during the 
study should not be captured as AEs, but should be listed in the medical history if related to a 
pre-existing condition.
9.7.1.1
Causality Assessment
For each AE, the investigator must provide an assessment of causal relationship to the study 
treatment. The causality assessment must be recorded on the eCRF. Causal relationship must 
be assessed by answering the following question:
Is there a reasonable possibility the study treatment caused the event?
Yes: There is evidence to suggest a causal relationship between the study treatment and AE, ie:

There is a reasonable temporal relationship between the study treatment and the event, 
and/or


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
The event is unlikely to be attributed to underlying/concurrent disease, other study 
treatments, or other factors, and/or

Positive dechallenge and/or rechallenge exist
No: There is no evidence to suggest a causal relationship between the study treatment and AE, 
ie:

There is no reasonable temporal relationship between the study treatment and the 
event, or

The patient did not take the study treatment, or

The event is likely to be attributed to underlying/concurrent disease, other study 
treatments, or other factors, or

The event is commonly occurring in the (study) population independent of study 
treatment exposure
9.7.1.2
Severity Assessment
The investigator will provide an assessment of the severity of each AE by recording a severity 
rating on the appropriate page of the patient’s eCRF. Severity, which is a description of the 
intensity of manifestation of the AE, is distinct from seriousness, which implies a patient 
outcome or AE-required treatment measure associated with a threat to life or functionality. 
Severity will be assessed according to the following scale:
Mild:
A type of AE that is usually transient and may require only minimal treatment 
or therapeutic intervention. The event does not generally interfere with usual 
activities of daily living.
Moderate:
A type of AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the research 
participant.
Severe:
A type of AE that interrupts usual activities of daily living, or significantly 
affects clinical status, or may require intensive therapeutic intervention.
9.7.1.3
Serious Adverse Event
An SAE is any untoward medical occurrence that at any dose:

Results in death

Is life threatening

Requires inpatient hospitalization or prolongation of existing hospitalization


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
Results in persistent or significant disability/incapacity, or

Is a congenital anomaly/birth defect
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based on appropriate medical judgment, they 
may jeopardize the patient and may require medical or surgical intervention to prevent one of 
the outcomes listed in this definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in patient hospitalization, or the development of 
study treatment dependency or drug abuse.
Emergency room visits that do not result in hospitalization should be evaluated for one of the 
other serious outcomes to determine whether they qualify as SAEs.
Preplanned hospitalizations (eg, elective procedures for pre-existing conditions that did not
worsen, such as cosmetic surgery and hysterectomy) are excluded from SAE reporting.
9.7.1.4
Reporting Adverse Events and Serious Adverse Events
At each visit, patients are to be queried regarding any AEs or SAEs that have occurred since 
the previous visit. Patients will be asked to volunteer information with a nonleading question 
such as, “How do you feel since your last visit?” Study site personnel will record all pertinent 
information in the patient’s eCRF.
All AEs must be recorded on the appropriate AE reporting page of the patient’s eCRF whether 
or not they are considered causally related to the study treatment.
For every AE, the investigator must:

Provide an assessment of the seriousness of the event (ie, is it an SAE?), as well as the 
severity and causal relationship

Document all actions taken with regard to the study treatment

Detail any other treatment measures taken for the AE

Document the outcome of the AE
In addition, patients are to be reminded, as described in the ICF and in accordance with 
Section 9.7.1, to notify site personnel of any AEs occurring during the 30 day post-study 
period. Any AEs reported by the patient (or patient representative) during this period are to be 
recorded in original source documents. AEs are also to be recorded in the eCRF if at least one
of the following conditions is met: 1) the event meets the criteria for an SAE (see 
Sections 9.7.1.3 and 9.7.1.5), and/or 2) the event is judged by the Investigator to be potentially 
causally related to study treatment.
Any AEs that are ongoing at the time of the final protocol-defined study visit will be followed 
until the condition returns to prestudy status, has resolved or stabilized, or can be explained as 


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being unrelated to the study treatment. If a follow-up visit is deemed necessary for appropriate 
safety surveillance, it will take place within 30 days of the final protocol-defined study visit.
9.7.1.5
Immediate Reporting of Serious Adverse Events and Events of Special Interest
The Sponsor is required to inform worldwide regulatory authorities of SAEs that meet specific 
criteria. Therefore, the Sponsor must be notified immediately regarding any SAE that occurs 
after informed consent is obtained.
Within 24 hours of learning of any AE that meets one of the criteria for an SAE, the study site 
personnel must report the event to AbbVie Global Drug Safety on the SAE Form for Clinical 
Trials. The Sponsor’s Study Physician may also be notified by telephone.
If, during follow-up, any nonserious AE worsens and eventually meets the criteria for an SAE, 
that AE should be recorded as a new SAE.
The site must transmit the SAE Form for Clinical Trials to the SAE fax number shown below. 
Even if an initial report is made by telephone, the SAE Form for Clinical Trials completed 
with all available details must still be faxed within 24 hours of knowledge of the event at the 
study site.
Supplemental information should be submitted as soon as available and may include 
laboratory results, radiology reports, progress notes, hospital admission and emergency room 
notes, holding and observation notes, discharge summaries, autopsy reports, and death 
certificates.
The investigator is expected to take all therapeutic measures necessary for resolution of the 
SAE. Any medications or procedures necessary for treatment of the SAE must be recorded on 
the appropriate pages of the patient’s eCRF. All SAEs are to be followed by the study staff 
until resolution or until the SAE is deemed stable. The Sponsor may contact the study site to 
solicit additional information or follow up on the event.
Fax the SAE Form for Clinical Trials to AbbVie Inc.
Global fax number for SAE or Pregnancy Reporting: 
1-714-796-9504 (backup fax 1-714-246-5295)
or email it to IR-Clinical-SAE@abbvie.com.
In case of fax failure or the site does not receive confirmation of receipt of the fax, the site 
must email the report to IR-Clinical-SAE@abbvie.com.
Medical Emergency phone number: 1-800-503-8745
9.7.1.6
Reporting of Pregnancies Occurring During the Study
Study site personnel must report every pregnancy from the time the patient signs the ICF until 
30 days after the last dose of study treatment. Within 24 hours of learning of the pregnancy, 
the study site personnel must report the event to Allergen Global Drug Safety on the Clinical 
Trial Pregnancy Form and fax it to the SAE/Pregnancy fax number stated in Section 9.7.1.5, 


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even if no AE has occurred. Pregnancies in female partners of male patients occurring during 
the time frame described above must also be reported.
The pregnancy must be followed to term and the outcome reported by completing a Clinical 
Trial Pregnancy Form. If the pregnancy is associated with an SAE (e.g., if the mother is 
hospitalized for hemorrhage), a separate SAE Form for Clinical Trials must be filed as 
described in Section 9.7.1.5 with the appropriate serious criterion (e.g., hospitalization) 
indicated in addition to the Pregnancy Form.
9.7.1.7
Potential Hy’s Law Cases
Criteria for potential Hy’s Law cases are as follows:

Alanine Aminotransferase or Aspartate Aminotransferase ≥ 3x upper limit of the 
normal range (ULN) AND

Total Bilirubin ≥ 2xULN AND

Alkaline Phosphatase < 2xULN
Study site personnel must report every patient who meets these potential criteria. Typically, all 
3 analytes will be obtained from the same sample, but they may come from multiple samples 
taken within a 24-hour period. This requirement applies from the time he or she signs the ICF 
for the trial until 30 days after the final protocol-defined study visit or the last known dose of 
study treatment (if the final visit does not occur).
A laboratory alert for potential Hy’s laws cases will be in place and must notify investigators 
and the Sponsor immediately when the above criteria have been met. A potential Hy’s law case 
must be faxed to the Sponsor on an AE of Special Interest Form as soon as possible (within 
24 hours of learning of the potential Hy’s law) to the SAE/Pregnancy fax number stated in 
Section 9.7.1.5, even if no AE has occurred. The eCRF for potential Hy’s law cases must be 
completed within 7 calendar days. Every effort to determine the cause of the liver enzyme 
abnormalities must be made, and close monitoring should be initiated in conjunction with the 
medical monitor and in accordance with the FDA “Guidance for Industry: Drug Induced 
Liver Injury-Pre-Marketing Clinical Evaluation” July 2009.
Medical Emergencies and Emergency Protocol Deviations
In medical emergencies, the investigator will use medical judgment and remove the patient from 
immediate harm. The investigator will then immediately notify the sponsor and the IRB 
regarding the type of emergency and the course of action taken.
An investigator shall notify the sponsor’s medical safety physician and the reviewing IRB of 
any deviation from the investigational plan to protect the life or physical well-being of a patient 
in an emergency. Such notice shall be given as soon as possible, but in no event later than 
5 working days after the emergency occurred. Except in such an emergency, prior approval by 
the sponsor is required for any changes in or deviations from the protocol. All deviations must be 
documented on the eCRF.






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9.8.2 Medical History
The patient’s medical history will be taken at Visits 1 and 2 (Pre-Amendment 3) or Visits A and 
B (Post-Amendment 3) and will include an account of the underlying disease state and its 
management, including CIC and current medications use.
9.8.3 Electrocardiograms
A 12-lead ECG will be recorded at screening. The investigator will evaluate the ECG tracing for 
any clinically significant abnormalities.
9.8.4 Concomitant Medication Use
Patients will be queried at each clinic visit concerning the use of medications. Concurrent 
medications used by the patients will be documented, including the name of the drug, the dose, 
the frequency, the route of administration, the date of initiation and discontinuation, and the 
reason for the medication.
Guidelines for prohibited drugs listed in the inclusion/exclusion criteria (Section 9.3.2) are to be 
followed.
9.8.5 Anticholinergic Symptoms Questionnaire
Patients/caregivers will be asked to complete an anticholinergic symptoms questionnaire at
Visits 2, 6, and 8 (Pre-Amendment 3) or Visits B, C, D, E, and F (Post-Amendment 3). The 
questionnaire will ask patients/caregivers to describe the intensity of any side effects that may be 
associated with the administration of anticholinergic medications (Appendix 5). Adverse events 
associated with the administration of anticholinergic medications detected on the 
questionnaire will be reported on the Adverse Event Form. The severity of the event and the 
relationship to the study drug will be assessed by the investigator and reported on the Adverse 
Event Form.
9.8.6 Vision Symptom Questionnaire
Post-Amendment 3, patients/caregivers will be asked to complete a Vision Symptom 
Questionnaire at Visits B, C, D, E, and F (Appendix 6). The questionnaire will ask 
patients/caregivers to describe any visual impairment or eye conditions for the patient.
Adverse events of vision disorders and/or symptoms detected on the Vision Symptom 
Questionnaire will be reported on the Adverse Event Form. The severity of the event and the 
relationship to the study drug will be assessed by the investigator and reported on the Adverse 
Event Form.
If a patient < 8 years old has started treatment and develops visual or ophthalmologic 
symptoms (ie, blurry vision, dry eye, dilated pupils, constant squinting, eyes drifting outward) 
it will be recommended that the patient is referred to a pediatric ophthalmologist for a 
comprehensive eye examination.


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9.9
Appropriateness of Measurements
Urinary diaries are non-invasive tools that provide a record of bladder function in neurogenic and 
non-neurogenic conditions. The data collected from these diaries give an indication of urinary 
patterns and severity of symptoms. The urinary diary can be used effectively to assess 
improvement of urinary incontinence during treatment and is an appropriate tool to use in this 
study.
Urodynamic measurements are the gold standard for evaluating bladder and sphincter function 
and for documenting the effectiveness of new drugs and treatment paradigms. Urodynamic data 
can provide supporting evidence of changes in bladder function following treatment with 
anticholinergics.
The safety assessments, including adverse events review, physical examination, vital signs, and 
laboratory evaluations represent standard evaluations in clinical studies evaluating 
anticholinergic agents. The assessment of skin erythema at the local application site is useful in 
determining the irritation potential of transdermal applications, like the oxybutynin topical gel.
The sparse blood sampling methodology is appropriate for this pediatric study, to minimize the 
amount of blood sampling and for the determination of average oxybutynin and 
N-desethyloxybutynin plasma concentrations.


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10
QUALITY CONTROL AND ASSURANCE
The sponsor will implement and maintain quality control procedures to ensure that this study is 
conducted, and data are generated, documented, and reported in compliance with the protocol, 
GCP, and applicable regulatory requirements.
The sponsor or designee will routinely conduct monitoring and/or auditing visits to the study 
centers to verify the adherence to the study protocol, the protection of the rights and well- being 
of the patients, and the accuracy and completeness of reported study data recorded on the source 
documentation.


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11
PLANNED STATISTICAL METHODS
11.1
Determination of Sample Size
Sample size was calculated for the protocol as originally designed (Pre-Amendment 3: double-
blind, placebo-controlled treatment period followed by an open-label extension) as follows:
This study was planned to include a minimum of 96 pediatric patients aged 6 to < 17 years who 
have a diagnosis of detrusor overactivity associated with a neurological condition. The sample 
size was selected to provide an adequate number of patients to evaluate the safety and efficacy of 
oxybutynin chloride gel treatment in a pediatric population. Patients were randomized in a 1:1 
fashion to oxybutynin chloride gel or placebo within each stratification level, which were based 
on age, weight, and gender. Estimates for the average change from baseline (CFB) in the 
percentage of catheterizations without a leaking accident as well as the standard deviation for 
this variable were taken from oxybutynin TDS in Study O03010. Assuming a common standard 
deviation of 28 for the CFB in the percentage of catheterizations without a leaking accident, a 
difference between treatment groups of 20 (assuming average for oxybutynin chloride gel = 25 
and average for placebo = 5), and n = 48 patients per treatment group, and then there is 93% 
power to detect a statistically significant difference between treatment groups. Based on 
discontinuation rates from Study O03010, if we assume a 10% dropout rate then there is 90% 
power to detect a statistically significant difference between treatment groups.
The open-label study (patients enrolled Post-Amendment 3) will include a minimum of 
25 pediatric patients aged 3 to < 17 years (efforts will be made to enroll a greater number of 
patients aged 3 years to < 6 years) who have a diagnosis of detrusor overactivity associated 
with a neurological condition. This sample size is expected to provide a minimum of 
10 patients with 14 weeks of exposure.
11.2
Analysis Populations and Databases
Statistical analysis and data tabulation will be performed using data from the open-label period 
for patients enrolled after Amendment 3 and the data from the double-blind and open-label 
periods for patients enrolled prior to Amendment 3 in the following patient populations unless 
specified otherwise:

Safety populations:
-
Post-Amendment 3 open-label safety population
-
Pre-Amendment 3 double-blind safety population
-
Pre-Amendment 3 open-label safety population
-
Combined open-label safety population (Pre- and Post-Amendment 3)

Intent-to-treat (ITT) populations:
-
Combined ITT population (Pre- and Post-Amendment 3; primary efficacy analysis 
population)
-
Post-Amendment 3 ITT population
-
Pre-Amendment 3 ITT population


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
Per-protocol (PP) populations:
-
Post-Amendment 3 PP population
-
Pre-Amendment 3 PP population

PK populations:
-
Post-Amendment 3 PK population
-
Pre-Amendment 3 PK population
-
Combined PK population (Pre- and Post-Amendment 3)
The Post-Amendment 3 open-label safety population is defined as all patients who receive at 
least 1 dose of study treatment in the open-label period after Amendment 3.
The Pre-Amendment 3 double-blind safety population is defined as all patients who receive at 
least 1 dose of study treatment in the double-blind period before Amendment 3.
The Pre-Amendment 3 open-label safety population is defined as all patients who receive at 
least 1 dose of study treatment in the open-label period before Amendment 3.
The combined open-label safety population is defined as all patients who receive at least 
1 dose of study treatment in the open-label period before or after Amendment 3.
The primary efficacy analysis populations will be the Post-Amendment 3 ITT population and 
the Pre-Amendment 3 ITT population.
The combined ITT population will include all patients who have a baseline value for the 
primary efficacy variable in the Post-Amendment 3 open-label period or all randomized 
patients who have a baseline value for the primary efficacy variable in the Pre-Amendment 3 
double-blind period.
The Post-Amendment 3 ITT population will include all randomized patients who have a 
baseline value for the primary efficacy variable in the Post-Amendment 3 open-label period.
The Pre-Amendment 3 ITT population will include all randomized patients who have a baseline 
value for the primary efficacy variable in the Pre-Amendment 3 double-blind period.
The Pre-Amendment 3 PP population will include all patients in the Pre-Amendment 3 ITT 
population who complete the double-blind treatment period of the study and who are without 
significant protocol violations.
The Post-Amendment 3 PP population will include all patients in the Post-Amendment 3 ITT 
population who complete the Post-Amendment 3 open-label treatment period of the study and 
who are without significant protocol violations.
The PK population will include all patients who have at least 1 sample draw for plasma 
concentrations. The PK population will only be used in the summary statistics and analyses of 
the PK data.


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Additionally, 2 types of visits are defined for the purposes of analysis and summary:

Observed cases (OC)

Last observation carried forward (LOCF)
The OC visits are defined to be those assessment values observed at each scheduled visit. All 
applicable efficacy and safety variables will be summarized using the OC visits.
The LOCF visit is defined as the last data recorded for each efficacy variable. This visit will be 
designated as Week 6 (LOCF). The Week 6 (LOCF) visit will be defined for the 
Post-Amendment 3 open-label period and the Pre-Amendment 3 double-blind period and will 
only be used to summarize efficacy data. The LOCF visit provides missing value imputation for 
patients who do not complete the open-label treatment period (Post-Amendment 3) or the 
double-blind treatment period (Pre-Amendment 3) of the study and will include all patients in 
the corresponding ITT population.
11.3
Efficacy Parameters
The primary efficacy variable for the Post-Amendment 3 open-label period and the Pre-
Amendment 3 double-blind period will be the percentage of catheterizations without a leaking 
accident (continuous variable).
The following are secondary continuous efficacy variables that will be calculated:

Average volume of urine collected per catheterization (for Pre-Amendment 3 population 
only)

Average volume of urine collected at first (morning awakening) catheterization 

Average number of catheterizations per day
The primary efficacy endpoint for the Post-Amendment 3 open-label period and the 
Pre-Amendment 3 double-blind period is defined as the CFB to Week 6 (LOCF) in the 
percentage of catheterizations without a leaking accident. The secondary efficacy endpoints are 
defined as the CFB in the secondary efficacy variables at Week 6 (LOCF).
Baseline is Visit 2 for Pre-Amendment 3, and baseline is Visit B for Post-Amendment 3.
11.4
Descriptive Summaries of Efficacy Parameters
Absolute values and CFB values for all the continuous efficacy parameters will be summarized 
for all visits, including Week 6 (LOCF), by dose level (0.5, 0.75, and 1.0 g and overall) for the 
Post-Amendment 3 ITT and PP populations and by treatment group (placebo and oxybutynin 
chloride gel) for the Pre-Amendment 3 ITT and PP populations using descriptive statistics 
including mean, 25th percentile, median, 75th percentile, SD, SEM, minimum, maximum, and 
number of patients. Additionally, the above descriptive summaries will be provided for each age 
group (3 to < 6 years, 6 to < 12 years, 12 to < 17 years), for each weight category within each
age group (≤ 18 kg and > 18 kg for the 3 to < 6 years-of-age group, ≤ 25 kg and > 25 kg for the 


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6 to < 12 years-of-age group, and ≤ 50 kg and > 50 kg for the 12 to < 17 years-of age group), and 
for each sex.
11.5
Statistical Analyses of Efficacy Parameters
All analyses will be conducted with SAS® v9.3 or higher using procedures appropriate for the 
particular analysis.
11.5.1 Statistical Analysis of the Primary Efficacy Endpoint
The primary efficacy parameter is the CFB to Week 6 (or LOCF) in the percentage of 
catheterizations without a leaking accident. The primary efficacy parameter will be analyzed 
using an analysis of covariance (ANCOVA) model with the baseline measure of the primary 
variable as the covariate and treatment group and study part (Pre-Amendment 3 and 
Post-Amendment 3) as factors.
To assess the effect of the study design, the primary efficacy parameter will be analyzed using 
a random effects mixed model using the combined data from the Pre-Amendment 3 double-
blind treatment period and the data from the Post-Amendment 3 open-label treatment period. 
The model will include the baseline measure and other baseline characteristics as covariates 
and treatment (Pre-Amendment 3 double-blind placebo, Pre-Amendment 3 double-blind 
oxybutynin chloride gel, Post-Amendment 3 open-label oxybutynin chloride gel) as factors and 
will account for the heterogeneity between parts of the study (Pre-Amendment 3 vs 
Post-Amendment 3) by using a random effect for study part. If the analyses indicate 
heterogeneity, the data from the Pre-Amendment 3 double-blind treatment period and the data 
from the Post-Amendment 3 open-label treatment period will be analyzed separately. For the 
Post-Amendment 3 ITT population, the significance of the change from baseline on the 
primary efficacy measure will be assessed from a 2-sided, 1-sample t-test. For the 
Pre-Amendment 3 ITT population the primary efficacy parameter will be analyzed using an 
ANCOVA model with the baseline measure of the primary variable as the covariate and 
treatment group as factors.
11.5.2 Statistical Analysis of the Secondary Efficacy Endpoints
For the Post-Amendment 3 ITT population, the analyses of the secondary efficacy parameters 
will assess the CFB for each variable at Week 6 (LOCF). The significance of the change from 
baseline on the secondary efficacy measures will be assessed from 2-sided, 1-sample t-tests. 
For the Pre-Amendment 3 ITT population, secondary efficacy parameters will be analyzed 
using ANCOVA models with the baseline measure of the efficacy variable as the covariate and 
treatment group as factor.
11.5.3 Additional Analyses
The primary and secondary efficacy endpoints will be analyzed at Week 6 LOCF) for each of 
the per-protocol populations. The analyses will be similar to those described for the primary 
and secondary efficacy endpoint analyses.


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The primary and secondary efficacy endpoints will be analyzed at each OC visit for each of the 
ITT and per-protocol populations. The analyses will be similar to those described for the 
primary and secondary efficacy endpoint analyses.
11.5.4 Subgroup Analyses
The primary and secondary efficacy data analyses will be analyzed separately for age groups, 
weight group, and sex group for each ITT population, as appropriate. Additionally, analysis of 
other important subgroups may be provided as well.
11.6
Safety Analysis
Safety variables will be summarized for each safety population using descriptive statistics and 
frequency distributions as defined in the following sections. Summaries will be provided overall 
and for each age group, weight group, and sex group.
11.6.1 Adverse Events
Key results will be presented for each safety population as follows:

Post-Amendment 3 open-label safety population: by oxybutynin chloride gel dose level 
and/or overall

Pre-Amendment 3 double-blind safety population: by treatment group and/or treatment 
and dose level, and/or overall

Pre-Amendment 3 open-label safety population: by treatment group in the lead-in 
double-blind period and overall

Combined open-label safety population: by oxybutynin chloride gel dose level and/or 
overall
The incidence of treatment-emergent adverse events will be summarized for the safety 
populations as described above. Adverse events will be coded using Medical Dictionary for 
Regulatory Activities (MedDRA) terminology. Summaries of the following types will be 
provided:

Overall summary of treatment-emergent adverse events

Summary of treatment-emergent adverse events by MedDRA system organ class, 
MedDRA preferred term, study treatment relationship, and severity

Summary of serious treatment-emergent adverse events by MedDRA system organ class, 
MedDRA preferred term, study treatment relationship, and severity

Summary of treatment-emergent adverse events by MedDRA preferred term and study
treatment relationship in descending order

Summary of treatment-emergent adverse events by MedDRA system organ class, 
MedDRA preferred term, and study treatment relationship for events leading to 
premature discontinuation from the study


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These summaries will present the number and percentage of patients reporting an adverse event 
for each classification level as well as the number of events reported. The denominators for 
calculating the percentages will be based on the number of patients in each safety population for 
each tabulated group.
All adverse events, SAEs, deaths, SAEs considered to be related to treatment, and adverse events 
leading to premature discontinuation from the study will also be provided in data listings.
11.6.2 Extent of Exposure
Summaries for duration of exposure for each safety population will be provided by treatment
group for the Pre-Amendment 3 double-blind period, and by exposure to oxybutynin chloride 
gel for each of the Pre-Amendment 3 and Post-Amendment 3 open-label periods and the 
Pre-Amendment 3 double-blind and open-label periods combined. Duration of exposure to 
study treatment will be summarized using descriptive statistics (mean, 25th percentile, median, 
75th percentile, SD, SEM, minimum, maximum, and number of patients). Duration of exposure 
will be calculated as the difference between the last dose date and the first dose date plus 1 day.
Additionally, these summaries will present the number and percentage of patients for each 
interval (1-week multiples) of total exposure. The denominators for calculating the percentages 
will be based on the number of patients with exposure.
11.6.3 Laboratory Evaluations and Abnormalities
Continuous clinical laboratory analytes will be summarized for each safety population by 
double-blind period treatment group, double-blind treatment/oxybutynin chloride gel sequence, 
or oxybutynin chloride gel only, as applicable, and by analyte and visit using descriptive 
statistics (mean, 25th percentile, median, 75th percentile, SD, SEM, minimum, maximum, and 
number of patients). Categorical laboratory analytes, classified as normal or abnormal, will be 
summarized for each safety population by DB treatment group or oxybutynin chloride gel only 
group as applicable, and analyte and visit using the number and percentage of patients in each 
category. The denominators for calculating the percentages will be based on the number of 
patients in each treatment group or oxybutynin chloride gel only group, as applicable, with 
nonmissing assessments at a particular visit for each safety population.
Shifts to values outside of the normal range will be presented as described above by 
summarizing the number and percentage of patients with evaluable shifts. An evaluable shift is 
one where both the baseline value (screening value) and the Pre-Amendment 3 Week 14 or 
Post-Amendment 3 Week 14 or ET values are recorded. The denominators for calculating the 
percentages will be based on the number of patients in each treatment group, double- blind 
treatment/ oxybutynin chloride gel sequence, or oxybutynin chloride gel only, as applicable
who have an evaluable shift for a particular analyte. Evaluable shifts to be presented are N→L, 
N→H, H→L, H→N, L→H, and L→N for continuous variables and normal→abnormal for 
categorical variables.
All clinical laboratory values, abnormal clinical laboratory values, and clinically significant 
laboratory values will also be provided in data listings.


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11.6.4 Vital Signs
Vital sign measurements will be summarized for each safety population by treatment group, 
double-blind treatment/ oxybutynin chloride gel sequence, or oxybutynin chloride gel only 
group, as applicable, and visit using descriptive statistics (mean, 25th percentile, median, 75th
percentile, SD, SEM, minimum, maximum, and number of patients). In addition, descriptive 
statistics will be presented for change from baseline (baseline is defined as Week 0 [Visit 2 for 
Pre-Amendment 3 and Visit B for Post-Amendment 3]) for systolic and diastolic blood 
pressures and heart rate.
11.6.5 Physical Examinations
Physical examination assessments will be summarized for each safety population by DB 
treatment group or oxybutynin chloride gel only group, as applicable, and visit. For each body 
system and assessment category, the number and percentage of patients will be presented. The 
denominators for calculating the percentages will be based on the number of patients evaluated 
for each body system.
11.6.6 Skin Assessments for Erythema
Skin assessments for erythema will be summarized for each safety population by treatment 
group and visit for the Pre-Amendment 3 double-blind period and by oxybutynin chloride gel
only and visit for the Pre-Amendment 3 open-label period, the Pre-Amendment 3 double-blind 
and open-label periods combined, and the Post-Amendment 3 open-label period. Additionally, 
skin assessments for erythema will be summarized over all visits for each of the above described 
summaries. Summaries will present the number and percentage of patients for each erythema 
category (none, mild, moderate, and severe). The denominators for calculating the percentages 
will be based on the number of patients with nonmissing assessments.
11.7
Other Assessments
11.7.1 Demographic and Other Pretreatment Characteristics
Patient demographic and physical characteristic data and medical history data will be 
summarized for each analysis population using descriptive statistics (mean, 25th percentile, 
median, 75th percentile, SD, SEM, minimum, maximum, and number of patients) for continuous 
variables and frequency distributions (number and percentage of patients) for categorical 
variables. Patient demographic data Pre-Amendment 3 will be summarized by double-blind 
period treatment group and overall for the double-blind period and by oxybutynin chloride gel
only for the open-label period and double-blind and open-label periods combined. Medical 
history data will be summarized by double-blind period treatment group and overall for 
double-blind period and by oxybutynin chloride gel only for the open-label period and double-
blind and open-label periods combined. Post-Amendment 3 patient demographic and medical 
history data will be summarized by oxybutynin chloride gel level and overall.
11.7.2 Medications
Medication usage will be coded using World Health Organization Drug Dictionary Enhanced 
Anatomical/Therapeutic/Chemical classification. Summaries of medications will be presented 
for the safety population by anatomical and therapeutic category and preferred name. 


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Pre-Amendment 3, summaries for the double-blind period will be provided by treatment and 
overall, and summaries for the open-label period and the double-blind and open-label periods 
combined will be provided for the oxybutynin chloride gel only group. Prior medication use and 
concomitant (on or after the first day of treatment) medication use will be documented and 
summarized separately. If the end date of prior medication occurs after treatment starts, then the 
medication will be reported as both prior and concomitant in the summaries. Summaries for 
Post-Amendment 3 will be provided by oxybutynin chloride gel dose level and overall.
11.7.3 Compliance
Compliance with the study treatment for each patient/visit will be calculated using the following 
formula:
Compliance = # of sachets dispensed −# returned
# expected
 ∗100
The expected number of sachets to be used for each patient will be based on the total number of 
treatment days. Compliance will be summarized by visit and over all visits using descriptive 
statistics (mean, 25th percentile, median, 75th percentile, SD, SEM, minimum, maximum, and 
number of patients) for the Pre-Amendment 3 double-blind safety population. Compliance will 
be summarized for the open-label periods by visit and over all visits using the same descriptive 
statistics.
11.7.4 Urodynamic Variables
Urodynamic variables will be summarized for the Pre-Amendment 3 double-blind and 
Post-Amendment 3 safety populations. Results will be presented by treatment group and visit 
and by treatment group, dose level, and visit for the Pre-Amendment 3 double-blind period and 
by oxybutynin chloride gel only and visit for the post-Amendment 3 open-label period using 
descriptive statistics (mean, 25th percentile, median, 75th percentile, SD, SEM, minimum, 
maximum, and number of patients) for continuous variables and frequency distributions (number 
and percentage of patients) for categorical variables. Summaries will be provided overall and for 
each age group and sex. In addition, descriptive statistics will be presented for change from 
baseline (baseline is defined as Week 0) for continuous urodynamic variables.
11.7.5 Anticholinergic Symptoms Questionnaire
Anticholinergic symptom questionnaire data will be summarized for the Pre-Amendment 3 
double-blind safety population by treatment group and visit and by treatment group, dose level, 
and visit for the double-blind period. Anticholinergic symptom questionnaire data will be 
summarized by oxybutynin chloride gel only and visit and by oxybutynin chloride gel only, 
dose level, and visit for the Pre-Amendment 3 open-label period and the Pre-Amendment 3 
double-blind and open-label periods combined, and for the Post-Amendment 3 open-label 
period. Summaries will be provided overall and for each age group and sex. Summaries will 
present the number and percentage of patients for each category. The denominators for 
calculating the percentages will be based on the number of patients with nonmissing values in 
each treatment group or oxybutynin chloride gel only group, or dose level and visit, as 
applicable. Additionally, shifts from baseline (baseline is defined at Week 0) for each question 


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will be provided for all evaluable shifts. An evaluable shift is one where both the baseline 
evaluation and on-treatment evaluations are recorded.
11.7.6 Vision Symptom Questionnaire
Vision symptom questionnaire data will be summarized for the Post-Amendment 3 safety 
population by visit and by dose level for the open-label period.
11.7.7 R- and S-Oxybutynin and N-desethyloxybutynin Plasma Concentrations
Plasma concentration data for oxybutynin and DEO plasma concentrations for the R-isomer, 
S-isomer, and R+S as well as the ratio of DEO to oxybutynin will be summarized for the 
pharmacokinetic population by visit. Summaries will be provided overall and for each age group 
and sex.
Linear or nonlinear regression, as appropriate, will be used to investigate the relationship 
between the CFB in the efficacy variables and plasma concentrations, age and plasma 
concentrations, weight and plasma concentrations, and body mass index and plasma 
concentrations for each visit.


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12
DATA HANDLING AND RECORDKEEPING
Electronic case report forms (eCRFs) will be designed and supplied by the sponsor. The eCRFs 
represent a record of the patient’s experience in the study. The data recorded in the eCRFs must 
be supported by original (or source) medical records, as appropriate. Data recorded directly on 
the eCRFs (ie, no prior written or electronic record of data) will be considered source data.
Prior to enrolling a patient in the study, the investigator must review all laboratory reports used 
for screening procedures. Documentation of this review must exist in the source documents 
(ie, the investigator must sign/initial and date the laboratory reports, etc) to provide evidence of 
the review and to indicate the date on which the review took place. The investigator will keep a 
log of all patients who are screened and record the reason(s) for their exclusion. eCRFs should 
be completed only for patients who receive study treatment.
Completion and correction of eCRFs will follow the instructions provided by the sponsor. 
Completed eCRFs will be electronically signed and dated by the investigator.
12.1
Data Generation and Analysis
After the site personnel complete data entry, electronic error and logic checks will be conducted 
to identify missing, incorrect, and/or out-of-range values. Discrepancies will be resolved through 
the system.
12.2
Access to Source Documentation
The investigator agrees that the sponsor or its designated agents, the IRB, and the FDA or foreign 
regulatory agencies will have reasonable access to study source documentation for purposes of 
audit and review both during and after completion of the study. These monitoring visits provide 
the sponsor with the opportunity to evaluate the progress of the study; to verify the accuracy and 
completeness of eCRFs; to assure that all protocol requirements, applicable regulations, and 
investigator’s obligations are being fulfilled; and to resolve any inconsistencies in the study 
records. All participating patients will be required to signify their approval to permit inspection 
of their medical records by representatives of the sponsor, the IRB, and the FDA and/or foreign 
regulatory agencies, as needed.
12.3
Retention of Data
In compliance with ICH guidelines, the investigator shall maintain adequate records for the 
study, including medical records, laboratory reports, consent forms, study treatment disposition 
records, safety reports, information regarding participants who discontinued, and other pertinent 
data. The investigator shall maintain these records for a period of at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study treatment. These records should be 
retained for a longer period if required by the applicable regulatory requirements or by an 
agreement with the sponsor. The sponsor will inform the investigator/institution as to when these 
records no longer need to be retained.


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13
OTHER INFORMATION
13.1
Financing and Insurance
Financing and insurance is addressed in a separate agreement.
13.2
Publication and Disclosure Policy
Publication and disclosure policy is addressed in a separate agreement.
13.3
Termination of the Study
If the study is terminated prematurely or suspended, all the appropriate IRB and regulatory 
authority (ies) will be promptly informed of the termination or suspension and will be provided 
the reason(s) for the termination or suspension. All obligations and responsibilities of the sponsor 
and the investigator under GCP, the US CFR, and the Declaration of Helsinki will remain in 
force if the study is terminated prematurely.


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14
REFERENCE LIST
1. Caramelli KE, Staskin DR, Volinn W. Steady-state pharmacokinetics of an investigational 
oxybutynin topical gel in comparison with oxybutynin transdermal system. Poster presented 
at Annual Meeting of the American Urological Association. May 17-22, 2008, Orlando, FL.
2. Caramelli KE, Thomas H, Stanworth S, Hoel G. Steady-state bioavailability of oxybutynin 
topical gel at 3 different application sites. Poster presented at Annual Meeting of the 
American Society of Consultant Pharmacists. November 19-22, 2008. New Orleans, LA.
3. Staskin DR, Dmochowski PR, Sand PK, MacDiarmid SA, Caramelli KE, Thomas H, Hoel G. 
Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: A randomized, 
double-blind, placebo-controlled, multicenter study. J Urol. 2009 Apr;181:1764-1772.
4. Bauer SB. Neurogenic bladder: etiology and assessment. Pediatr Nephrol. 2008;23:541-551.
5. Franco I, Horowitz M, Grady R. Adams RC, De Jong T, Lindert K, Albrecht D. Efficacy and 
safety of oxybutynin in children with detrusor hyperreflexia secondary to neurogenic bladder 
dysfunction. J Urol. 2005 Jan;173:221-225.
6. Aslan AR, Kogan B. Conservative management in neurogenic bladder dysfunction. Curr 
Opin Urol. 2002;12:473-447.
7. A Multi-Center, Open-Label, Active-Controlled, Dose-Titration Study Evaluating the Safety, 
Efficacy and Pharmacokinetics of Oxybutynin Transdermal Systems in the Treatment of 
Detrusor Overactivity Associated with a Neurological Condition in Pediatric Subjects, 
Followed by a 12-Week Open-Label Safety Extension Study. Watson Study O03010, 2008.
8. Verpoorten C, Buyse G. The neurogenic bladder: medical treatment. Pediatr Nephrol 
2008;23:717-725.
9. Chou FH, Ho CH, Chir MB, Lisenmeyer TA. Normal ranges of variability for urodynamic 
studies of neurogenic bladders in spinal cord injury. J Spinal Cord Medicine 2006;29:26-31.
10. Haferkamp, A Steahler G. Gerner HJ, Dorsam J. Dosage escalation of intravesical 
oxybutynin in the treatment of neurogenic bladder patients. Spinal Cord 2000;38:250-254.


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15
APPENDICES
Appendix 1
Schedule of Events
Appendix 2
Clinical Laboratory Evaluations 
Appendix 3
Sample 2-Day Urinary Diary 
Appendix 4
Urodynamic Evaluation
Appendix 5
Anticholinergic Symptoms Questionnaire
Appendix 6
Vision Symptom Questionnaire for Parent/Caregiver
Appendix 7
Gel Application Instructions
Appendix 8
Vision Assessment Instructions for Site


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Appendix 1
Schedule of Events
Post-Amendment 3
Evaluation:
ScreeningPeriod
Open-Label Treatment Period
Visit A1
Visit B
Visit C
Visit D
Visit E
Visit F/ET
-13 to -5 Days
Week 0
Week 2
Week 6
Week 10
Week 14
Informed Consent
X
I/E Criteria
X
X
Medical History
X
X
Vision Assessment inChildren
< 8 years
X2
ConcomitantMedication
X
X
X
X
X
X
DemographicInformation
X
Physical Examination
X
X
Height and Weight
X
Vital Signs
X
X
X
X
X
X
12-Lead ECG
X
Serum Chemistries
X
X
Hematology
X
X
Urinalysis
X
X3
X
Urine Culture
X
Urine Pregnancy Test4
X
X
X
Urodynamics
X
X
Dispense 2-day UrinaryDiary
X
X
Collect 2-day UrinaryDiary
X
X
Local ErythemaAssessment5
X
X
X
X
Adverse EventAssessment
X
X
X
X
Anticholinergic Questionnaire
X
X
X
X
X
Vision SymptomQuestionnaire
X
X
X
X
X
Collect PK Sample &Record
Date/Time
X
X
X
Dose Titration (ifnecessary)
X
Study TreatmentDispensing
X6
X6
X
X
Study TreatmentCompliance
X
X
X
X
1
All patients taking anticholinergic medications will be asked to discontinue treatment and complete a 3-day
washout period (11-day washout period if the patient was previously taking solifenacin).
2
Vision Assessment is required prior to or at the Baseline Visit for patients < 8 years of age, at the time of
screening who have not received a vision screening assessment within the last 12 months prior to screening.
3
A urine sample for on-site urinalysis to determine presence of bacterial infection will be collected.
4
Urine pregnancy test will only be performed for females of childbearing potential.
5
Assessment for local erythema at application site
6
Instruct patient/caregiver on study treatment application.


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Appendix 2
Clinical Laboratory Evaluations
Hematology (performed on whole blood)
Hemoglobin
Mean cell volume
Hematocrit
While blood cell (WBC) & differential
Red blood cell (RBC) count
Platelet count
Chemistry (performed on serum)
Albumin
Glucose
Alanine aminotransferase (ALT)
Lactate dehydrogenase (LDH)
Aspartate aminotransferase (AST)
Total bilirubin
Blood urea nitrogen (BUN)
Total protein
Gamma glutamyl transferase (GGT)
Creatinine
Sodium
Chloride
Potassium
Bicarbonate
Calcium
Phosphorus
Urinalysis (performed on urine)
Ketones
Protein
Specific gravity
Glucose
Potential for hydrogen (pH)
Blood
Appearance
Leukocyte esterase
Bilirubin
Microscopic examination
Other Labs (performed on urine)
Urine culture1
Urine pregnancy test2
1
At screening only.
2
Urine pregnancy test will only be performed for females of childbearing potential.


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Appendix 3
Sample 2-Day Urinary Diary
Instruction to Study Coordinator:
1. Complete the PATIENT Initials and PATIENT Number at the top of each diary page AND
on the cover page, prior to providing the diary to the study participant and/or caregiver.
2. Instruct the study participant and/or caregiver on how and when to complete the diaryand to 
return the completed diary at their next visit.
Instructions for Study Participant and/or Caregiver:
1. Complete the urinary diary for 2 days in a row (Day 1 and Day 2) prior to your nextvisit.
2. Begin each day of the diary with the first catheterization after waking for the dayand 
continue collecting required information until you/your child wake up the next morning.
3. Record the actual date for each day of the diary (day month year). For example:

If Day 1 is 03 Jan 2011, then Day 2 will begin with the first catheterization afterwaking
on 04 Jan 2011.
4. Collect and record the actual volume of first (morning awakening) catheterization on Day 1
and Day 2.

Use the supplied collection container to collect and measure the urine from the 
first (morning awakening) catheterization.

Record the volume of urine collected with first (morning awakening) catheterization in 
cubic centimeters (cc) or milliliters (mL) in the VOLUME column of your diary.
5. Record the number of catheterizations during the day; note: the volume needs to be recorded
only for the first (morning awakening) catheterization.
6. Check the Yes or No box in the LEAKAGE column of your diary, indicating if anyleakage 
occurred since the last catheterization.
7. Bring the completed diary with you to your next visit.


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Instruction to Study Coordinator upon return of diary:
1. Review the diary entries with the study participant and/or caregiver at the start of the visit.
2. If additional information is added to the diary to clarify an entry based on your review, 
include this information and initial/date your entries.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 4
Urodynamic Evaluation
The following procedures outline a standard clinical urodynamic evaluation. The Life-Tech 
Urovision system (or comparable system) with strip chart recording will be used for data 
collection. All equipment will be appropriately set up and regularly calibrated.
1.
Patient will report to the urodynamic laboratory at the scheduled time.
2.
Informed written consent and assent (if applicable) will be obtained from patient and 
parent/legal guardian.
3.
After CIC the patient will assume the lithotomy position and will be prepped and draped 
in a sterile fashion.
4.
All components of the urodynamic equipment will be checked for proper calibration and 
function.
5.
The urethra will be lubricated, and anesthetized with lidocaine jelly, as needed.
6.
The patient will be catheterized with a triple-lumen urodynamic catheter of a size 
appropriate for the pediatric patient (the smaller the better).
7.
A small balloon catheter should be inserted into the rectum to measure intra-abdominal 
pressure.
8.
The filling phase of the cystometrogram will be initiated by infusing water or saline 
through the side-hole channel at a rate of 10-25 mL/min in the supine or sitting position.
9.
Pressure data from the bladder and rectal catheters will be recorded.
10. Captured urodynamic data will include:

Maximal bladder capacity

Detrusor pressure at maximum bladder capacity

Maximum amplitude of involuntary detrusor contractions

Volume at first involuntary detrusor contraction

Presence (versus total absence) of involuntary detrusor contractions at > 15 cm H2O.


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Appendix 5
Anticholinergic Questionnaire


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Appendix 6
Vision Symptom Questionnaire for Parent/Caregiver
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
  
 
 
 
 
 
  
   
 
 
  
 
 
 


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Appendix 7
Gel Application Instructions
The instructions below are for gel application by patient or caregiver:

Bathing or showering should not occur sooner than 1 hour after gel application.

If bathing before application, the area must be dried completely before gel application.

Tear open the pouch at the indentation and express the complete contents either into your 
hand or directly on the abdomen, upper arm/shoulder, or thigh application area (see 
diagram on following page).

Gently spread the gel on the application area in a continuous line covering as much of the 
application area as possible. It should be spread as uniformly and thinly as possible over 
the entire application area taking care not to transfer any material to any clothing. Care 
should also be taken not to apply gel to the area in or immediately around the naval 
during the abdominal applications.

Gently work the gel into the skin over the entire application area until it dries. Do not 
continue rubbing after the gel had dried. Within 5 minutes after application, wash your 
hands thoroughly with soap and warm water.

After application, the application site should be covered with clothing after the gel has 
dried (eg, a shirt or pants). In the event that unwashed or unclothed skin to which the gel 
has been applied comes in direct contact with the skin of another person within a day of 
application, the general area of contact on the other person should be washed with soap 
and water as soon as possible.




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Appendix 8
Vision Assessment Instructions for Site
Visual acuity-LEA symbols

Visual acuity is screened at a distance of 10 feet using the Lea symbols.

The child need not know these symbols, but must be able to match the indicated 
symbols on a wall chart with those on the response card.
Equipment

10' Lea Vision Chart Student Response Card Flashcards

Table and chair

Occluder with lip
Facilities

Room approximately 15 feet long or greater, well–lit and without glare.
Procedure
Testing the right eye:
1.
The child must be standing or sitting at a table with the response card in front, eyes at 
a 10-foot distance from the chart.
2.
The child must be conditioned to match symbols by pointing to the same symbol on 
the response card as is being shown with a flash card or pointed to on the chart.
3.
Begin screening with one person holding an occluder over the child's left eye.
4.
Another person points to the symbols on the Lea wall chart using caution not to cover 
the rectangle line with their finger or pointer.
5.
The child should point to the corresponding symbol on the response card.
6.
Start with the top line and continue downward showing one letter per line. If the child 
reaches the bottom line, show the remaining three symbols.
7.
If the child misses, go to the line above and show four different symbols in that line. If 
the child matches them correctly, proceed downward.
8.
To receive credit for a line, the child must correctly match each of the four different 
symbols on the line.
9.
The number recorded as the visual acuity is the smallest line the child can read 
correctly.
Testing the left eye

Cover the right eye and repeat the procedure
Age five PASS
10/15 or better in each eye without a 2-line difference.
Re-screen/REFER
10/20 or worse in either eye or a 2-line difference in the pass range
Age three to four PASS
10/20 or better in each eye without a 2-line difference
Re-screen/REFER
10/25 or worse in either eye or a 2-line difference in the pass range.


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Considerations for screening special populations:

The matching of the Lea symbols may be practiced before the screening

For some children with special needs it may be useful to reproduce the response card, 
cut and space them so that larger movements can be used when indicating the 
matching symbol.
NOTE: At recheck, the poorer eye should be screened first. Children unable to perform the 
Lea chart should be given the procedures designed for younger children. Occluders should be 
cleaned between children.
Reminders:

The detection of vision disorders and symptoms during the study will be tracked by the 
adverse event reporting process. The severity of the event and the relationship to the 
study drug will be assessed by the investigator and reported on the Adverse Event 
Form.

Any patients with asymmetric/unequal or severe refractive error will be excluded from 
the study since aforementioned conditions can result in refractive amblyopia and may 
confound the study outcomes.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 

SAP_001.pdf: 
Allergan Confidential
SAP OG09002 Oxybutynin Chloride 10% Gel
1
1.
Title Page
STATISTICAL ANALYSIS PLAN
A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety,
Pharmacodynamics, and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the 
Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric
Patients
Final 2.0: 2022-03-28
Protocol Number:
OG09002 Protocol Amendment 3
Development Phase:
4 
Product Name:
Oxybutynin Chloride 10% Gel
Study Statistician:
PhD (Version 1.0)
 PhD (Version 2.0)
 PhD (Version 2.0)
Sponsor:                                                Allergan Sales, LLC
2525 Dupont Drive
Irvine, CA 92612
This document is the property of Allergan Sales, Inc. and may not, in full or part, be passed on, 
reproduced, published, distributed to any person, or submitted to any regulatory authority 
without the express written permission of Allergan Sales, Inc.
 
 
 
NCT01192568


Allergan Confidential
SAP OG09002 Oxybutynin Chloride 10% Gel
2
2.
Table of Contents
1.
Title Page.............................................................................................................................1
2.
Table of Contents .................................................................................................................2
2.1
List of Tables ..............................................................................................................3
3.
List of Abbreviations and Definition of Terms......................................................................5
4.
Introduction..........................................................................................................................6
4.1
Study Design Summary...............................................................................................6
4.2
Study Objectives and Endpoints..................................................................................7
4.3
Schedule of Events......................................................................................................9
5.
Statistical Methodology and Study Endpoints.....................................................................11
5.1
Statistical Methods Planned in the Protocol and Determination of Sample Size.........11
5.1.1
Statistical and Analytical Plans......................................................................11
5.1.1.1
Common Conventions.....................................................................11
5.1.1.2
Demographics .................................................................................14
5.1.1.3
Efficacy and Pharmacodynamic Analyses........................................17
5.1.1.4
Safety Analyses...............................................................................22
5.1.1.5
Other Assessments ..........................................................................28
5.1.1.6
Subgroup Analyses..........................................................................29
5.1.1.7
Interim Analyses .............................................................................29
5.1.2
Determination of Sample Size .......................................................................30
5.2
Changes in the Conduct of the Study or Planned Analyses ........................................30
5.2.1
Changes in the Conduct of the Study.............................................................30
5.2.2
Changes to Analyses Prior to Database Lock .................................................31
6.
Data Handling and Analysis Conventions...........................................................................32
6.1
Study Treatment Conventions ...................................................................................32
6.1.1
Analysis Days ...............................................................................................32
6.1.2
Missing/Incomplete Treatment End Date.......................................................32
6.2
Analysis Visit Windows ............................................................................................32
6.2.1
Efficacy.........................................................................................................32
6.2.2
Safety and Other Assessments .......................................................................33
6.3
Missing/Incomplete Date Conventions......................................................................34
6.3.1
Missing/Incomplete AE Start Date.................................................................35
6.3.2
Missing/Incomplete Medication Start Date....................................................35
6.3.3
Missing/Incomplete AE/Medication End Date ...............................................35
 
 
 


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6.4
Safety Endpoint Conventions....................................................................................35
6.4.1
Adverse Events..............................................................................................35
6.4.1.1
Missing Intensity or Relationship ....................................................35
6.4.2
Clinical Laboratory Assessments ...................................................................36
6.4.2.1
Potentially Clinically Significant Criteria ........................................36
6.4.2.2
Continuous Descriptives and Shift Table Parameters .......................36
6.4.2.3
Character Values..............................................................................37
6.4.3
Vital Signs.....................................................................................................37
6.4.3.1
Continuous Descriptives Parameters................................................37
6.5
Imputed Value Listing Conventions...........................................................................37
Appendix 1
Schedule of Events for Pre-Amendment 3 .....................................................38
2.1
List of Tables
Table 3-1
Abbreviations and Definitions of Terms ...............................................................5
Table 5-1
Analysis Populations..........................................................................................12
Table 5-2
Statistical Methodology......................................................................................13
Table 5-3
Missing Data Handling by Endpoint Type ..........................................................14
Table 5-4
Analysis Population Summaries.........................................................................14
Table 5-5
Participant Disposition Summaries.....................................................................15
Table 5-6
Protocol Deviation Summary .............................................................................15
Table 5-7
Demographic Summaries ...................................................................................16
Table 5-8
Medical History Summary .................................................................................16
Table 5-9
Medication Summaries.......................................................................................17
Table 5-10
Efficacy and Pharmacodynamic Assessments.....................................................17
Table 5-11
Efficacy and Pharmacodynamic Endpoint Baseline Definitions..........................18
Table 5-12
Efficacy and Pharmacodynamic Analyses ..........................................................19
Table 5-13
Safety Endpoint Baseline Definitions.................................................................22
Table 5-14
Study Treatment Summaries...............................................................................23
Table 5-15
AE Terms...........................................................................................................24
 
 
 


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Table 5-16
AE Summaries...................................................................................................25
Table 5-17
Clinical Laboratory Summaries..........................................................................26
Table 5-18
Potential Hy’s Law Summaries ..........................................................................26
Table 5-19
Vital Signs Summaries .......................................................................................27
Table 5-20
Physical Examination Summaries ......................................................................27
Table 5-21
Skin Assessment for Erythema Summaries.........................................................28
Table 5-22
Anticholinergic Questionnaire Summaries..........................................................28
Table 5-23
Vision Questionnaire Summaries........................................................................29
Table 6-1
Analysis Day Definitions ...................................................................................32
Table 6-2
Efficacy Analysis Visit Definitions for Pre-Amendment 3 Double-Blind 
Treatment Period................................................................................................33
Table 6-3
Efficacy Analysis Visit Definitions for Post-Amendment 3 Open-Label Treatment 
Period ................................................................................................................33
Table 6-4
Safety Analysis Visit Definitions for Pre-Amendment 3 .....................................33
Table 6-5
Safety Analysis Visit Definitions for Post-Amendment 3 Open-Label Treatment 
Period ................................................................................................................34
Table 6-6
Imputation Scenarios..........................................................................................34
Table 6-7
Initial Imputed Date Algorithm ..........................................................................35
Table 6-8
Missing AE Intensity and Relationship Imputation Algorithms...........................35
Table 6-9
Clinical Laboratory PCS Criteria........................................................................36
Table 6-10
Clinical Descriptive and Shift Table Parameters.................................................36
Table 6-11
Vital Sign Descriptive Parameters ......................................................................37
 
 
 


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3.
List of Abbreviations and Definition of Terms
Table 3-1
Abbreviations and Definitions of Terms
Abbreviation/Term
Definition
AE
adverse event
ANCOVA
analysis of covariance
ATC
Anatomical Therapeutic Chemical
CFB
change from baseline
CIC
clean intermittent catheterization
DEO
N-desethyloxybutynin
ECG
electrocardiogram, electrocardiographic
eCRF
electronic case report form
GCP
Good Clinical Practice
ICH
International Conference on Harmonisation
ITT
intent-to-treat
LOCF
last observation carried forward
LS
least squares
MedDRA
Medication Dictionary for Regulatory Activities
OC
observed cases
PCS
potentially clinically significant
PK
pharmacokinetic
PP
per-protocol
PT
preferred term
SAE
serious adverse event
SAP
statistical analysis plan
SEM
standard error of mean
SI
Le Système International d’Unités (International System of Units)
SOC
system organ class
TEAE
treatment-emergent adverse event
WHO
World Health Organization


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4.
Introduction
This statistical analysis plan (SAP) details comprehensive, technical specifications of the 
statistical analyses of the efficacy and safety data outlined and/or specified in the final protocol 
of Study OG09002. Specifications of tables, figures, and data listings are contained in a separate 
document. Statistical analysis plan for pharmacokinetics data will be addressed separately.
This document is organized into 3 main sections:
1. Study overview including study design and objectives
2. Statistical Methodology and Study Endpoints
3. Data Handling and Analysis Conventions
4.1
Study Design Summary
This study was initiated as a double-blind, placebo-controlled study with an open-label extension 
and was amended via protocol amendment (Protocol Amendment 3) to enroll participants under 
only open-label treatment. Therefore, analyses are described with respect to prior to protocol 
amendment 3 (“pre-amendment 3”) and with protocol amendment 3 (“post-amendment 3”).
Prior to Amendment 3, participants aged 6 years to < 17 years who had a diagnosis of detrusor 
overactivity associated with a neurological condition and were using clean intermittent 
catheterization (CIC) to control bladder function were randomly assigned 1:1 to receive double-
blind oxybutynin chloride gel or placebo gel for 6 weeks. Enrollment was stratified based on sex, 
age, and weight. Stratification was done within the following groups: male and female; 6 to < 12 
years-of-age and 12 to < 17 years-of-age; and by weight category: ≤ 25.0 kg and > 25.0 kg for 
the 6 to < 12 years-of-age group and ≤ 50.0 kg and > 50.0 kg for the 12 to < 17 years-of age 
group. Enrollment into the 6-week treatment period was to be followed by an open-label, 8-week 
period to generate safety data. All participants began treatment with 0.75 g of gel/day for 2 
weeks. Participants then returned to the clinic at Week 2 for a potential dose titration and at this
time their dose could have been adjusted up to 1 g/day, down to 0.5 g/day, or remained the same 
at 0.75 g/day. The determination of dose was based on the investigator’s clinical judgment and 
assessment of the patient’s bladder symptoms and treatment side effects. Dose titration was 
permitted only once during the entire 6-week double-blind, placebo-controlled period. 
Participants continued blinded treatment for 4 additional weeks until the end of the double-blind 
treatment period.
Post-Amendment 3, the study became a multicenter, open-label, dose-titration study in pediatric 
participants, ages 3 years to < 17 years, with detrusor overactivity associated with a neurological 
condition. A minimum of 25 participants are to be enrolled. Efforts will be made to enroll a 
greater number of participants from the ages of 3 years to < 6 years. Participants must be suitable 
 
 
 


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candidates for anticholinergic therapy and must be using CIC for bladder control. The study will 
include a screening period from Day -13 to Day -5 and a 14-week open-label treatment period. 
The expected duration of the study for each patient will be up to 16 weeks (which includes 2 
weeks of screening and 14 weeks of treatment). There are six clinic visits (Visit A – Visit F). No
changes were made in the starting dose, compared to the Pre-Amendment 3 study design, in that 
all participants will begin treatment with 0.75 g of gel/day for 2 weeks. Participants will then
return to the clinic for a potential dose titration and at this time their dose may be adjusted up to 
1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day, depending on individual response 
and tolerability. The determination of dose will be based on the investigator’s clinical judgment 
and assessment of the patient’s bladder symptoms and treatment side effects. Dose titration will 
be permitted only once during the entire 14-week treatment period (at Visit C, Week 2).
Participants will continue the adjusted dose for 12 additional weeks until the end of the open-
label treatment period.
Safety will be evaluated by monitoring adverse events, physical examinations, vital signs,
clinical laboratory evaluations, skin erythema at the application site, and a vision symptom
questionnaire.
4.2
Study Objectives and Endpoints
Each study objective is presented with endpoint(s) below:
Objectives
Endpoints
Primary

Pre-Amendment 3: To evaluate the 
efficacy of daily treatment with 
oxybutynin chloride gel compared to 
placebo in pediatric participants during 
the first 6 weeks (i.e., the double-blind 
treatment period) of a 14-week treatment 
period
Post-Amendment 3: To evaluate the 
efficacy of daily treatment with 
oxybutynin chloride gel in pediatric 
participants during the first 6-weeks of a 
14-week open-label treatment period
Primary Efficacy Endpoints

Change from baseline to Week 6 of 
treatment or to the last observation carried 
forward (LOCF) in the percentage of 
catheterizations without a leaking accident 
as recorded in the 2-day urinary diary 
Secondary Efficacy Endpoints
Change from baseline to Week 6 of 
treatment in the following (calculated from 
the 2-day urinary diary data):
o
Average volume of urine collected per 
catheterization (for Pre-Amendment 3 
population only)
o
Average volume of urine collected at 
first (morning awakening) 
catheterization
o
Average number of catheterizations 
per day




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4.3
Schedule of Events
Post-Amendment 3
Evaluation:
Screening 
Period
Open-Label Treatment Period
Visit A1
Visit B
Visit C
Visit D
Visit E
Visit F/ 
ET
-13 to -5 Days
Week 0
Week 2
Week 6
Week 10
Week 
14
Informed Consent
X
I/E Criteria
X
X
Medical History
X
X
Vision Assessment in 
Children < 8 years
X2
Concomitant Medication
X
X
X
X
X
X
Demographic 
Information
X
Physical Examination
X
X
Height and Weight
X
Vital Signs
X
X
X
X
X
X
12-Lead ECG
X
Serum Chemistries
X
X
Hematology
X
X
Urinalysis
X
X3
X
Urine Culture
X
Urine pregnancy test4
X
X
X
Urodynamics
X
X
Dispense 2-day Urinary 
Diary
X
X
Collect 2-day Urinary 
Diary
X
X
Local  Erythema 
Assessment 5
X
X
X
X
Adverse Event 
Assessment
X
X
X
X
Anticholinergic 
Questionnaire
X
X
X
X
X
Vision Symptom 
Questionnaire
X
X
X
X
X
Collect PK Sample & 
Record Date/Time
X
X
X
Dose Titration (if 
necessary)
X
Study Drug Dispensing
X6
X6
X
X
Study Treatment 
Compliance
X
X
X
X


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1
All participants taking anticholinergic medications will be asked to discontinue treatment and complete a 3-day 
washout period (11-day washout period if the patient was previously taking solifenacin).
2
Vision Assessment is required prior to or at the Baseline Visit for participants < 8 years of age, at the time of
        screening who have not received a vision screening assessment within the last 12 months prior to screening.
3
A urine sample for on-site urinalysis to determine presence of bacterial infection will be collected.
4
Urine pregnancy test will only be performed for females of childbearing potential.
5
Assessment for local erythema at application site.
6
Instruct patient/caregiver on study treatment application.
Pre-Amendment 3
The schedule of events for Pre-Amendment 3 is found in Appendix 1 of this document.
 
 
 


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5.
Statistical Methodology and Study Endpoints
5.1
Statistical Methods Planned in the Protocol and Determination of 
Sample Size
This SAP will be approved prior to database lock. The SAP expands the statistical section of the 
protocol and contains a detailed description of methods to analyze data collected in the study. 
The text portion of the SAP will be included in the CSR report as Appendix 16.1.9. 
5.1.1
Statistical and Analytical Plans
Statistical analyses will be conducted using SAS Version 9.3 or newer.
5.1.1.1
Common Conventions
5.1.1.1.1
Analysis Populations
The analysis populations will consist of participants as defined below, where analysis 
populations are formed relative to the protocol under which a participant was enrolled.
Participants enrolled prior to protocol amendment 3 are referred to as “pre-amendment 3,” and 
participants enrolled under protocol amendment 3 or later are referred to as “post-amendment 3.”
For example, the pre-amendment 3 safety population consists of all treated participants who 
received blinded study treatment and may have also received open-label active treatment. The 
post-amendment 3 safety population consists of all treated participants who received open-label 
active treatment. Details are below with categorizations based on double-blind or open-label 
treatment.
 
 
 


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Table 5-1
Analysis Populations
Population
Definition
Study Treatment
Post-Amendment 3 open-
label Safety
All participants who receive at least 1 dose of study treatment in 
the open-label period who are enrolled under Amendment 3 or 
later
Actual received1
Pre-Amendment 3 
double-blind Safety
All participants who receive at least 1 dose of study treatment in 
the double-blind period, which is only applicable to participants 
who enrolled prior to Amendment 3
Actual received1
Pre-Amendment 3 open-
label Safety
All participants who receive at least 1 dose of study treatment in 
the open-label period before Amendment 3
Actual received1
Combined open-label 
Safety (Pre- and Post-
Amendment 3)
All participants who receive at least 1 dose of study treatment in 
the open-label period before or after Amendment 3
Actual received1
Post-Amendment 3 
Intent-to-Treat (ITT)2
All participants who receive at least 1 dose of study treatment and 
have at least one post-baseline value for the primary efficacy 
variable in the Post-Amendment 3 open-label period
Actual received1
Pre-Amendment 3 
(Intent-to-Treat) ITT2
All randomized participants who have at least one post-baseline
value for the primary efficacy variable in the Pre-Amendment 3 
double-blind period
Randomized 
assignment
Combined Intent-to-Treat 
(ITT2) (Pre- and Post-
Amendment 3)
All participants who receive at least 1 dose of study treatment and 
have at least one post-baseline value for the primary efficacy 
variable in the Post-Amendment 3 open-label period and all 
randomized participants who have at least one post-baseline value 
for the primary efficacy variable in the Pre-Amendment 3 double-
blind period
Actual received
or Randomized 
assignment3
Post-Amendment 3 Per-
Protocol (PP)
All participants in the Post-Amendment 3 ITT population who 
complete the Post-Amendment 3 open-label treatment period of 
the study and who are without significant protocol violations
Actual received1
Pre-Amendment 3 Per-
Protocol (PP)
All participants in the Pre-Amendment 3 ITT population who 
complete the double-blind treatment period of the study and who 
are without significant protocol violations
Randomized 
assignment
1
Participants will be summarized according to the study treatment received for majority of the treatment period.
2
The primary efficacy variable in the description of each ITT population definition is the change from baseline 
(CFB) to Week 6 of treatment or the last observation carried forward (LOCF) in the percentage of 
catheterizations without a leaking accident as recorded in the 2-day urinary diary.
3
Actual treatment received for Post-Amendment 3 open-label data and Randomized treatment for Pre-
Amendment 3 double-blind treatment period data.
5.1.1.1.2
Study Treatments
The following treatment groups are defined for this study:

Oxybutynin chloride gel in the Post-Amendment 3 open-label period (titrated dose levels 
of 0.5, 0.75, and 1.0 g of oxybutynin chloride gel per day)

Placebo in the Pre-Amendment 3 double-blind period 

Oxybutynin chloride gel in the Pre-Amendment 3 double-blind period (titrated dose 
levels of 0.5, 0.75, and 1.0 g of oxybutynin chloride gel per day)

Oxybutynin chloride gel in the Pre-Amendment 3 open-label period (titrated dose levels 
of 0.5, 0.75, and 1.0 g of oxybutynin chloride gel per day)


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5.1.1.1.3
Statistical Methodology
The methodologies defined below apply as specified to individual endpoints defined in this SAP. 
When indicated, two-sided 95% confidence intervals and two-sided p-values will be presented. 
Individual endpoint analyses may specify exceptions (additions or deletions) to these general 
definitions.
Table 5-2
Statistical Methodology
Methodology
Description
Categorical counts

Number of participants in individual categories
o
Participants with ≥ 1 qualifying event counted once per individual category
Categorical 
descriptives

Number and percentage of participants in individual categories
o
Participants with ≥ 1 qualifying event counted once per individual category
o
N1 = participants with a non-missing baseline value
Shift analysis

Number and percentage of participants in individual baseline and postbaseline 
categories

Percentage denominator = number of participants in individual baseline categories

N1 = participants with non-missing values at both baseline and the specified 
postbaseline analysis visit

Shifts include: Normal →Low, Normal →High, High →Low, High →Normal, 
Low →High, Low →Normal for continuous variables and Normal →Abnormal for 
categorical variables
Continuous 
descriptives

N1, mean, standard deviation (SD), median, minimum, maximum, 25th percentile, 
75th percentile, standard error of mean (SEM) for a visit in an analysis group

N1 = participants with non-missing value for a visit in an analysis group
CFB descriptives

Continuous descriptives for baseline, postbaseline, and change from baseline (CFB) 
values for an analysis group

N1 = participants with non-missing values at both baseline and the specified 
postbaseline analysis visit for an analysis group
CFB one-sample t-
test

Estimates derived from one-sample t-test at an analysis visit (observed case [OC] or 
LOCF, e.g., Week 6 LOCF) for an analysis group
o
mean and 95% confidence interval (CI)
o
P-value

N1=participants with non-missing values at both baseline and the specified 
postbaseline analysis visit (in the Post-Amendment 3 ITT and PP populations and in 
the Pre-Amendment 3 and Post-Amendment 3 ITT and PP populations, including 
for each sex, within an age group, or within an weight category within an age 
group)
CFB ANCOVA

Continuous descriptives and standard error (SE) for baseline, postbaseline, and CFB 
values at an analysis visit (e.g., Week 6 LOCF)

Estimates derived from a model for CFB value controlling for factors (treatment 
group) and covariates (baseline value)
o
Least squares (LS) means and standard errors
o
LS mean differences, and 95% confidence intervals for oxybutynin chloride 
gel vs Placebo
o
P-values from contrast t-test comparing oxybutynin chloride gel vs Placebo

N1 = participants with non-missing values at both baseline and the specified 
postbaseline analysis visit
Exact (Clopper-
Pearson) 95% CI

Exact 95% CI for a single proportion


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Methodology
Description
Exact 
unconditional 95% 
CI using the score 
statistic

Exact 95% CI for difference between two proportions
Cochran-Mantel-
Haenszel (CMH)

P-value from CMH test controlling for baseline covariates
Kolmogorov-
Smirnov test

P-value from exact Kolmogorov-Smirnov test to examine whether two distributions 
are the same
CFB = change from baseline; ANCOVA = analysis of covariance.
Raw and derived data listings will be provided, and will be fully defined in the table, figure, and 
data listing specification document.
5.1.1.1.4
Missing Data
General missing data handling conventions for methodologies in Section 5.1.1.1.3 are 
summarized as follows:
Table 5-3
Missing Data Handling by Endpoint Type
Parameter type
Timing
Missing Data Handling
CFB ANCOVA
Treatment Period

If missing a covariate:
o
Participant excluded

If missing derived value at the specified post-baseline analysis 
visit:
o
Available cases (i.e., observed case [OC] analysis)

Participant excluded
o
Last observation carried forward (LOCF)

Participant included using LOCF-imputed 
value (last non-missing post-baseline value 
before the missing value is carried forward 
to impute the missing value). Baseline value
will not be carried forward.
5.1.1.2
Demographics
5.1.1.2.1
Analysis Populations
The distribution of participants within the analysis populations will be summarized as follows:
Table 5-4
Analysis Population Summaries
Population 
Description
Methodology
Combined open-label 
safety
Distribution by titrated dose level and 
overall 
Categorical counts
Combined ITT 
Distribution by study part and treatment 
group, oxybutynin chloride gel dose level 
and all gel dose levels as applicable
Categorical counts


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5.1.1.2.2
Participant Disposition
Participant disposition encompasses the distribution of participants who enter, complete, and 
discontinue, along with eCRF-reported discontinuation reasons. Participant disposition will be 
summarized as follows:
Table 5-5
Participant Disposition Summaries
Parameter
Description
Timing
Methodology
Completion and 
discontinuation
Summary completion and discontinuation 
status, including summary of reasons for 
discontinuation
—
Categorical 
descriptive
ITT population 
summary
Distribution in the combined ITT 
population in total and by treatment group; 
and by study part in total and by treatment 
group
—
Categorical 
descriptives
5.1.1.2.3
Protocol Deviations
Protocol deviations will be defined in a separate document, including importance classification. 
Protocol deviations will be summarized as follows:
Table 5-6
Protocol Deviation Summary
Parameter
Description
Timing
Methodology
Important protocol 
deviations
Distribution in the combined ITT 
population in total and by treatment group; 
and by study part in total and by treatment
group
—
Categorical 
descriptives
5.1.1.2.4
Demographics and Baseline Characteristics
Demographics and baseline characteristics will be summarized as follows:

Combined ITT population: double-blind period by treatment group and overall and open-
label periods by oxybutynin chloride gel dose level and overall

Combined open-label safety population: by oxybutynin chloride gel dose level and 
overall

Post-Amendment 3 open-label safety population: by oxybutynin chloride gel dose level 
and overall
The following demographic and baseline characteristics will be summarized as described below:


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Table 5-7
Demographic Summaries
Parameter
Description
Timing
Methodology
Age
Age (years) relative to informed consent 
date
Informed consent
Continuous 
descriptives
Age group

3 to < 6 years

6 to < 12 years

12 to <17 years
Informed consent
Categorical 
descriptives
Sex, race, and 
ethnicity

eCRF categories

Race group
o
White
o
Non-white
Screening Period
Categorical 
descriptives
Baseline 
characteristics

Height (m)

Weight (kg)

Body mass index (BMI)
Weight (kg) / height (m)2
Latest assessment in 
Screening Period
Continuous 
descriptives
Baseline 
characteristics

Age and Weight Category
o
<=18 kg and 3 to < 6 
years
o
>18 kg and 3 to < 6 years
o
<=25 kg and 6 to < 12 
years
o
>25 kg and 6 to < 12 
years
o
<=50 kg and 12 to <17 
years
o
>50 kg and 12 to <17 
years
Latest assessment in 
Screening Period
Categorical 
descriptives
5.1.1.2.5
Medical History
The results of urinary and bowel movement history will be presented for each analysis 
population as follows:

Combined open-label safety population: by oxybutynin chloride gel dose level and 
overall

Post-Amendment 3 open-label safety population: by oxybutynin chloride gel dose level 
and overall

Pre-Amendment 3 double-blind safety population: by treatment group and overall
Other medical history will be presented in a listing. 
Urinary and bowel movement history reported as occurring before the Screening Visit will be
summarized by treatment group or dose level for the safety populations as follows:
Table 5-8
Medical History Summary
Parameter
Description
Timing
Methodology
Urinary and Bowel 
Movement history
Urinary and Bowel Movement history was 
present before the Screening Visit
Screening Period
Categorical 
descriptives


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5.1.1.2.6
Prior and Concomitant Medications
Prior medication and concomitant medication use will be summarized separately. The results of 
prior and concomitant medications will be presented for safety populations as follows:

Combined open-label safety population: by oxybutynin chloride gel dose level and 
overall

Post-Amendment 3 open-label safety population: by oxybutynin chloride gel dose level 
and overall

Pre-Amendment 3 double-blind safety population: by treatment group and overall
Medications will be coded using the World Health Organization (WHO) Drug Dictionary, 
Version WHODRUG DDE + HD 3Q2016 or newer. Unique participants who reported 
medications will be summarized by Anatomical Therapeutic Chemical (ATC) 4 class and PT in 
total and for each group or groups defined above for the respective safety population as follows:
Table 5-9
Medication Summaries
Parameter
Description
Timing
Methodology
Prior medications
Medications taken ≥ 1 time before the 
study treatment start date, regardless of 
medication end date
Screening Period 
Categorical 
descriptives
Concomitant 
medications
Medications taken ≥ 1 time on or after the 
study treatment start date, regardless of 
medication start date
Treatment Period
Categorical 
descriptives
ATC4 classes will be sorted alphabetically; PTs will be sorted in descending frequency in the highest dose group.
5.1.1.3
Efficacy and Pharmacodynamic Analyses
Efficacy analyses will be based on each ITT and PP Population. Pharmacodynamic analyses will 
be based on the ITT Population.
The following efficacy assessments and terms are defined:
Table 5-10
Efficacy and Pharmacodynamic Assessments
Assessment/Term
Description
Urinary diaries 
  The following parameters are evaluated:

Number of catheterizations per day

Volume of urine collected at each (after morning awakening) 
catheterization

Leakage incidents between catheterizations
Urodynamic Assessment
The following parameters are evaluated:

Maximal bladder capacity 

Detrusor pressures at maximum bladder capacity

Maximum amplitude of involuntary detrusor contractions

Volume at first involuntary detrusor contraction

Presence (versus total absence) of involuntary detrusor contractions at > 
15 cm H2O


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Assessment/Term
Description
Baseline assessments for applicable efficacy and pharmacodynamic endpoints defined as 
follows:
Table 5-11
Efficacy and Pharmacodynamic Endpoint Baseline Definitions
Endpoint
Description
Timing
Parameters in Urinary 
diaries and Urodynamic 
Assessment   
The available value at the baseline visit
Visit 1/Visit 21 for Pre-Amendment 
3,
Visit A/Visit B for Post-Amendment 
3
1   Visit 1/Visit 2 and Visit A/Visit B are defined in Section 6.2.1.
5.1.1.3.1
Efficacy Endpoints
The primary efficacy endpoint is the change from baseline (CFB) to Week 6 in the percentage of 
catheterizations without a leaking accident as recorded in the 2-day urinary diary.
Distributions for the primary endpoint between participants treated with oxybutynin chloride gel 
in the two different types of treatment periods (Pre-Amendment 3 double-blind treatment period 
or Post-Amendment 3 open-label treatment period) of the study will be compared.  Specifically, 
an exact two-sample Kolmogorov-Smirnov test will be used to compare the two distributions, 
with a p-value of 0.05 used as the threshold to reject the null hypothesis that the distributions for 
the two periods are the same.
If the distributions of the endpoint between these two periods are similar (p ≥ 0.05), the primary 
analysis of the primary efficacy endpoint analysis will compare the difference between 
oxybutynin chloride gel and placebo in the Combined ITT population for the change from 
baseline in the percentage of catheterizations without a leaking accident at Week 6 using an 
analysis of covariance (ANCOVA) model with the baseline measure of the primary variable as 
the covariate and treatment group (active or placebo) as the factor.
If the distributions for the endpoint show a significant difference (p < 0.05) between these two 
periods, the data from the Pre-Amendment 3 double-blind treatment period and the data from the 
Post-Amendment 3 open-label treatment period will be analyzed separately as the primary 
analysis:

For Pre-Amendment 3, the primary endpoint analysis will compare the difference 
between oxybutynin chloride gel and placebo in the Pre-Amendment 3 ITT population
for the change from baseline in the percentage of catheterizations without a leaking 
accident at Week 6 using an ANCOVA model with the baseline measure of the primary 
variable as the covariate and treatment group as the factor.


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
For Post-Amendment 3, a 2-sided one-sample t-test will be used on the primary endpoint 
to test for a significant difference from zero in the Post-Amendment 3 ITT population.
The analysis method which is not used as the primary analysis will serve as a supplementary 
analysis of the primary endpoint.
Secondary endpoints include the change from baseline to Week 6 of treatment in:

average volume of urine collected per catheterization

average volume of urine collected at first (morning awakening) catheterization

average number of catheterizations per day
Analysis populations and methodologies for secondary endpoints will be handled similarly to the 
primary endpoint.  For each secondary endpoint, an exact two-sample Kolmogorov-Smirnov test 
will be used to compare the two distributions, with a p-value of 0.05 used as the threshold to 
determine the main analysis method for that endpoint (i.e., the main analysis will use the 
combined ITT population if p ≥ 0.05, and the main analysis will analyze the treatment periods
separately if p < 0.05).
Efficacy variables will be analyzed as described in the following table. The urinary diary 
endpoints will be analyzed for the ITT and PP analysis populations at Week 6 (LOCF), and for 
ITT and PP analysis populations at each OC Visit. The pharmacodynamic endpoints will be 
analyzed for the ITT population.
Table 5-12
Efficacy and Pharmacodynamic Analyses
Endpoint
Description
Timing
Methodology
Percentage of 
catheterizations without a 
leaking accident
Change from baseline to Week 6 (or 
LOCF) calculated over 2 diary days
Pre-Amendment 3
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Percentage of 
catheterizations without a 
leaking accident
Raw value for Week 6 (or LOCF) 
calculated over 2 diary days
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period
Continuous 
descriptives
Percentage of 
catheterizations without a 
leaking accident
Change from baseline to OC Visits 
(Week 2, Week 6) calculated over 2 
diary days
Pre-Amendment 3 
Week 2, Week 6 of 
double-blind period; 
Post-Amendment 3 
Week 6 of open-
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test


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Endpoint
Description
Timing
Methodology
label period; 
Combined ITT (OC)
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Percentage of 
catheterizations without a 
leaking accident
Raw value for OC Visits (Week 0, 
Week 2, Week 6) calculated over 2 
diary days
Pre-Amendment 3 
Week 0, Week 2, 
Week 6 of double-
blind period;
Post-Amendment 3 
Week 0, Week 6 of 
open-label period
Continuous 
descriptives
Average volume of urine 
collected at first (morning 
awakening) catheterization
Average change from baseline to 
Week 6 (or LOCF) calculated over 2 
diary days 
Pre-Amendment 3 
Week 6 (LOCF) of
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Average volume of urine 
collected at first (morning 
awakening) catheterization
Average raw value for Week 6 (or 
LOCF) calculated over 2 diary days
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period
Continuous 
descriptives
Average volume of urine 
collected at first (morning 
awakening) catheterization
Average change from baseline for 
OC Visits (Week 2, Week 6) 
calculated over 2 diary days
Pre-Amendment 3 
Week 2, Week 6 of 
double-blind period;
Post-Amendment 3 
Week 6 of open-
label period; 
Combined ITT (OC)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Average volume of urine 
collected at first (morning 
awakening) catheterization
Average Raw value for OC Visits 
(Week 0, Week 2, Week 6) 
calculated over 2 diary days
Pre-Amendment 3
Week 0, Week 2, 
Week 6 of double-
blind period;
Post-Amendment 3 
Week 0, Week 6 of 
open-label period
Continuous 
descriptives
Average number of 
catheterizations per day
Average change from baseline to 
Week 6 (or LOCF) calculated over 2 
diary days
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test
Post-Amendment 3; 
ANCOVA for 
Combined ITT
Average number of 
catheterizations per day
Average raw value for Week 6 (or 
LOCF) calculated over 2 diary days
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period
Continuous 
descriptives


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Endpoint
Description
Timing
Methodology
Average number of 
catheterizations per day
Average change from baseline for 
OC Visits (Week 2, Week 6) 
calculated over 2 diary days
Pre-Amendment 3 
Week 2, Week 6 of 
double-blind period;
Post-Amendment 3 
Week 6 of open-
label period; 
Combined ITT (OC)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Average number of 
catheterizations per day
Raw value for OC Visits (Week 0, 
Week 2, Week 6) calculated over 2 
diary days
Pre-Amendment 3 
Week 0, Week 2, 
Week 6 of double-
blind period;
Post-Amendment 3 
Week 0, Week 6 of 
open-label period
Continuous 
descriptives
Average volume of urine 
collected per catheterization 
(for Pre-Amendment 3 
population only)
Change from baseline to Week 6 (or 
LOCF) calculated over 2 diary days
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period
CFB ANCOVA Pre-
Amendment 3 
Average volume of urine 
collected per catheterization 
(for Pre-Amendment 3 
population only)
Average raw value for Week 6 (or 
LOCF) calculated over 2 diary days
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period
Continuous 
descriptives
Average volume of urine 
collected per catheterization 
(for Pre-Amendment 3 
population only)
Change from baseline for OC Visits 
(Week 2, Week 6) calculated over 2 
diary days
Pre-Amendment 3 
Week 2, Week 6 of 
double-blind period
CFB ANCOVA Pre-
Amendment 3 
Average volume of urine 
collected per catheterization 
(for Pre-Amendment 3 
population only)
Average raw value for OC Visits 
(Week 2, Week 6)  calculated over 2 
diary days
Pre-Amendment 3 
Week 0, Week 2, 
Week 6 of double-
blind period
Continuous 
descriptives
Maximal bladder capacity
Change from baseline to Week 6 (or 
LOCF)
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test 
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Detrusor pressure at 
maximal bladder capacity
Change from baseline to Week 6 (or 
LOCF)
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test 
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT


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Endpoint
Description
Timing
Methodology
Maximum amplitude of 
involuntary detrusor 
pressure
Change from baseline to Week 6 (or 
LOCF)
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test 
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Volume at first involuntary 
detrusor contraction
Change from baseline to Week 6 (or 
LOCF)
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CFB ANCOVA Pre-
Amendment 3; CFB 
one-sample t-test 
Post-Amendment 3; 
CFB ANCOVA for 
Combined ITT
Presence (versus total 
absence) of involuntary 
detrusor contractions at > 15 
cm H2O
Raw value at Week 6 (or LOCF)
Pre-Amendment 3 
Week 6 (LOCF) of 
double-blind period; 
Post-Amendment 3 
Week 6 (LOCF) of 
open-label period; 
Combined ITT 
(LOCF)
CMH test 
Pre-Amendment 3; 
Exact 95% CI
Post-Amendment 3; 
CMH test for 
Combined ITT
1   Weeks are defined in Section 6.2.1.
5.1.1.4
Safety Analyses
Safety analyses will be based on each safety population.
Baseline assessments for applicable safety endpoints defined as follows:
Table 5-13
Safety Endpoint Baseline Definitions
Parameter
Description
Timing

Clinical laboratory evaluations

Vital signs

Physical Examination

Skin Assessments for 
Erythema
eCRF- or (standardized) vendor-provided 
assessments
Latest non-missing 
assessment 
on/before treatment 
start date


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5.1.1.4.1
Study Treatment Exposure and Compliance
Study treatment exposure and compliance will be summarized by treatment group or oxybutynin 
chloride gel level, as applicable, and by visit and overall for each safety population as follows:
Table 5-14
Study Treatment Summaries
Parameter
Description
Timing
Methodology
Study treatment 
exposure (days)
Date of last dose of the study drug minus Date of  
first dose of the study drug + 1
Study Period 
within a 
Study Part1
Continuous 
descriptives
Categorical study 
treatment exposure
Number and percentage of participants exposed 
to treatment during each of the following 
intervals:

Week (0, 1]

Week (1, 2]

Week (2, 3]

Week (3, 4]

Week (4, 5]

Week (5, 6]

Week (6, 7]

Week (7, 8]

Week (8, 9]

Week (9, 10]

Week (10, 11]

Week (11, 12]

Week (12, 13]

Week (13, 14]

Week >=14
Study Period 
within a 
Study Part1
Categorical 
descriptives
Study treatment 
compliance (%)
Summary by period interval 
Pre-Amendment 3:
100 ×
# of sachets dispensed  – # returned
         # expected 
Post-Amendment 3:
100 ×
# of sachets taken
         # expected
Study Period 
within a 
Study Part1
Continuous 
descriptives
1   Study part refers to pre-amendment 3 and post-amendment 3; pre-amendment 3 has both open-label and double-
blind periods, post-amendment 3 has only open-label period.


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5.1.1.4.2
Adverse Events
Adverse event summaries will be presented for each safety population as follows:

Post-Amendment 3 open-label safety population: by oxybutynin chloride gel dose level 
and overall

Pre-Amendment 3 double-blind safety population: by treatment group, treatment 
and dose level, and overall

Pre-Amendment 3 open-label safety population: by oxybutynin chloride gel dose level 
and overall

Combined open-label safety population: by oxybutynin chloride gel dose level and 
overall
Adverse event summaries will be done overall and also for each age, weight, and sex group.
The following adverse event (AE) terms are defined:
An AE will be considered as a treatment-emergent adverse event (TEAE) if the AE initially 
occurs or increases in intensity on or after the first dose of study drug in the study. An event that 
occurs more than 30 days after the last dose of study drug will not be considered as treatment-
emergent.
Table 5-15
AE Terms
Term
Description
Treatment-
emergent 
Double-blind period:

First dose date of double-blind period ≤ event start date ≤ last dose date of double-blind 
period + 30 days if participant does not enter the 8-week open-label period;  or 

First dose date of double-blind period ≤ event start date < first dose date of open-label 
period if participant enters the 8-week open-label period
Open-label period:

First start date of open-label period ≤ event start date ≤ last dose date of open-label 
period + 30 days
AEs, encompassing abnormalities and surgeries reported as occurring after the Screening Visit, 
will be coded using MedDRA Version 19.1 or later. Unique participants reporting AEs in the 
following AE categories will be summarized for the groups defined above for each safety 
population as follows:


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Table 5-16
AE Summaries
Parameter
Description
Timing
Methodology
Overall summary
Overall summary only for the 
following category:

Treatment-emergent AEs 
(TEAEs)
Study Period within
Study Part2,3 ; 
Combined open-label 
period
Categorical 
descriptives
TEAE
Overall summary and by SOC and PT
Study Period within
Study Part2,3 ; 
Combined open-label 
period
Categorical 
descriptives
TEAEs by severity 
Overall summary and by SOC, PT, and 
intensity

Participants categorized 
overall and within each SOC 
and PT for the most intense 
occurrence
Study Period within
Study Part2,3; Combined 
open-label period
Categorical 
descriptives
TEAE by study 
treatment relationship
Overall summary and by SOC, PT, and 
study treatment relationship in 
descending order
Study Period within
Study Part2,3 ; 
Combined open-label 
period
Categorical 
descriptives
Serious TEAEs by 
study treatment 
relationship and 
severity 
Overall summary and by SOC, PT, 
study treatment relationship and 
intensity

Participants categorized 
overall and within each SOC 
and PT for the most intense 
occurrence
Study Period within
Study Part2,3 ; 
Combined open-label 
period
Categorical 
descriptives
TEAEs leading to 
premature 
discontinuation1
Overall summary and by SOC, PT and 
study treatment relationship
Study Period within
Study Part2,3 ; 
Combined open-label 
period
Categorical 
descriptives
1   Participants who report ≥ 1 AE in the AE category and all AEs for those participants will be listed.
SOCs will be sorted alphabetically; PTs will be sorted in descending frequency in the highest dose group.
2   Study part refers to pre-amendment 3 and post-amendment 3; pre-amendment 3 has both open-label and double-    
blind periods, post-amendment 3 has only open-label period.
3    AEs with onset more than 30 days after the last dose of study drug are excluded from analysis.
5.1.1.4.3
Clinical Laboratory Assessments
Clinical laboratory assessments will be summarized by treatment group, double-blind 
treatment/oxybutynin chloride gel sequence, or oxybutynin chloride gel only group, as 
applicable, and by analyte and visit for each safety population. Study Part is either Pre-
Amendment 3 or Post-Amendment 3.


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Table 5-17
Clinical Laboratory Summaries
Endpoint
Description
Timing
Methodology
Descriptives 
Summary of change from baseline by laboratory 
category and parameter in SI units and analysis 
visit

Parameters specified in Section 6.4.2.2
Visit F1 for Post-
Amendment 3 and 
Visit 8 for Pre-
Amendment 3
CFB 
descriptives
Descriptives
Summary of raw values by laboratory category 
and parameter in SI units and analysis visit

Parameters specified in Section 6.4.2.2
Visits A and F1
for Post-
Amendment 3 and 
Visits 1 and 8 for 
Pre-Amendment 3
Continuous 
descriptives
Shift from baseline2
Summary by laboratory category and parameter

Low, normal, and high categories 
provided by the central laboratory

Parameters specified in Section 6.4.2.2
End of Period 
within a Study 
Part2
Shift analysis
1    Pre-Amendment 3 Week 14 or End of Treatment within Pre-Amendment 3; Post-Amendment 3 Week 14 or End 
of Treatment within Post-Amendment 3
2    Study part refers to pre-amendment 3 and post-amendment 3; pre-amendment 3 has both open-label and double-
blind periods, post-amendment 3 has only open-label period.
Laboratory assessments values meeting any of the PCS low or PCS high criteria specified in 
Section 6.4.2.1 will be identified as PCS in the laboratory data listing.
5.1.1.4.3.1
Potential Hy’s Law
Potential Hy’s Law criteria will be summarized by treatment group, double-blind 
treatment/oxybutynin chloride gel sequence, or oxybutynin chloride gel only group, as 
applicable, and visit for each open-label safety population as follows:
Table 5-18
Potential Hy’s Law Summaries
Endpoint
Description
Timing
Methodology
Potential Hy’s Law 
within 24-hour window
Postbaseline assessment of the following 
laboratory parameters based on blood draws 
collected within a 24-hour period:

ALT or AST ≥ 3 × ULN and

TBL ≥ 2 × ULN and

ALP < 2 × ULN
Study Period 
within Study Part1
Categorical 
descriptives
Potential Hy’s Law 
without window
(e-DISH)
Postbaseline assessment of the following 
laboratory parameters at any time:

Maximum ALT or AST ≥ 3 × ULN

Maximum TBL ≥ 2 × ULN
Study Period 
within Study Part1
Categorical 
descriptives
e-DISH = evaluation of drug-induced serious hepatotoxicity.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; TBL = total bilirubin.
ALP = alkaline phosphatase; ULN = upper limit of normal.
1   Study part refers to pre-amendment 3 and post-amendment 3; pre-amendment 3 has both open-label and double-
blind periods, post-amendment 3 has only open-label period.


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5.1.1.4.4
Vital Signs
Vital signs will be summarized by treatment group, double-blind treatment/oxybutynin chloride 
gel sequence, or oxybutynin chloride gel only group, as applicable, and visit for each safety 
population as follows:
Table 5-19
Vital Signs Summaries
Endpoint
Description
Timing
Methodology
Descriptives
Summary of change from baseline by 
parameter and analysis visit
Parameters specified in Section  6.4.3.1
Pre-Amendment 3 
Weeks 1 to 6; Post-
Amendment 3 Visits 
B, C, D, E, and F1
CFB
descriptives
Descriptives 
Summary of raw values by parameter and 
analysis visit
Parameters specified in Section  6.4.3.1
Pre-Amendment 3 
all double-blind 
visits; Post-
Amendment 3 Visits 
A, B, C, D, E, and 
F1
Continuous CFB 
descriptives
Descriptives 
Summary of raw values and change from 
baseline by parameter and analysis visit
Parameters specified in Section  6.4.3.1
Combined open-
label period
Continuous CFB 
descriptives
1    Analysis visits defined in Section 6.2.2.
5.1.1.4.5
Physical Examination
Physical examination assessments will be summarized for each safety population by double-
blind treatment group or oxybutynin chloride gel only group, as applicable, and visit. 
Table 5-20
Physical Examination Summaries
Endpoint
Description
Timing
Methodology
Each body system at a 
visit rated 
(Normal/Abnormal)1
Summary of number and percentage of 
subjects Normal at baseline who shifted to 
Abnormal post-baseline by parameter and 
analysis visit
Visits 8 and F2, 
Combined open-
label period
Categorical CFB 
descriptives
1    The denominator for calculating the percentages will be based on the number of patients evaluated for a body    
system at the visit who were rated as Normal for the body system.
2    Analysis visits defined in Section 6.2.2.
5.1.1.4.6
Skin Assessment for Erythema
Skin assessments for erythema will be summarized for each safety population by treatment group 
and visit for the Pre-Amendment 3 double-blind period and by oxybutynin chloride gel only and 
visit for the Pre-Amendment 3 open-label period, the Pre-Amendment double-blind and open-
label periods combined, and the Post-Amendment 3 open-label period. Additionally, skin 
assessments for erythema will be summarized by visit for each of the above described. 


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Table 5-21
Skin Assessment for Erythema Summaries
Endpoint
Description
Timing
Methodology
Each erythema 
category (none, mild, 
moderate, severe) 1
Summary by parameter and analysis visit
Visits C, D, E, and 
F2
Categorical CFB 
descriptives
1   Participants who have non-missing assessments. 
2    Analysis visits defined in Section 6.2.2.
5.1.1.5
Other Assessments
5.1.1.5.1
Anticholinergic Questionnaire
Anticholinergic symptom questionnaire data will be summarized for the Pre-Amendment 3
double-blind safety population by treatment group and visit and by treatment group, dose level, 
and visit for the double-blind period. Anticholinergic symptom questionnaire data will be 
summarized by oxybutynin chloride gel only and visit and by oxybutynin chloride gel only, dose 
level, and visit for the Pre-Amendment 3 open-label period and the Pre-Amendment 3 double-
blind and open-label periods combined, and for the Post-Amendment 3 open-label period.  
Additionally, shifts from baseline for each question will be provided for all evaluable shifts. An 
evaluable shift is one where both the baseline evaluation and on-treatment evaluations are 
recorded.
Table 5-22
Anticholinergic Questionnaire Summaries
Endpoint
Description
Timing
Methodology
Each question on the 
questionnaire1 overall 
and by age group and 
sex
Categorical summary of number and 
percentage of participants in a response 
category (no, mild, tolerable, or 
intolerable, applicable) by question and 
analysis visit; shift tables summarizing 
the shift in categorical response from 
baseline to each post-baseline visit (for 
Pre-Amendment 3 and also for Post-
Amendment 3)
Pre-Amendment 3 
Weeks 0, 6, and 14; 
Post-Amendment 3 
Visits B, C, D, E, 
and F2
Categorical 
descriptives
1    Participants who have non-missing assessments. 
2    Analysis visits defined in Section 6.2.2.
5.1.1.5.2
Vision Questionnaire
Visit symptom questionnaire data will be summarized for the Post-Amendment 3 Open-Label 
Safety Population by visit overall and for each dose level.


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Table 5-23
Vision Questionnaire Summaries
Endpoint
Description
Timing
Methodology
Each question on the 
questionnaire (yes, no)1
Summary by question and analysis visit
Post-Amendment 3 
Visits B, C, D, E, 
and F2
Categorical 
descriptives
1    Participants who have non-missing assessments. 
2    Analysis visits defined in Section 6.2.2.
5.1.1.6
Subgroup Analyses
The primary and secondary efficacy LOCF data analyses will be analyzed separately for each
group for each ITT population, as appropriate:
Age Group:

3 to < 6 years

6 to < 12 years

12 to < 17 years
Weight Category by Age Group:

<=18 kg and 3 to < 6 years

>18 kg and 3 to < 6 years

<=25 kg and 6 to < 12 years

>25 kg and 6 to < 12 years

<=50 kg and 12 to <17 years

>50 kg and 12 to <17 years
Sex:

Male

Female
Here the same analysis methodologies as the primary and secondary analyses will be applied for 
the ITT populations (See Section 5.1.1.1.3, CFB ANCOVA). ANCOVA will be performed for each 
subgroup if the sample size available is at least 14 subjects. The Wilcoxon signed-rank test will 
be used when the one-sample t-test is not valid (See Section 5.1.1.1.3, CFB one -sample t-test). 
Additionally, analysis of other important subgroups may be provided as appropriate.
5.1.1.7
Interim Analyses
Not applicable.


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5.1.2
Determination of Sample Size
Sample size was calculated for the protocol as originally designed (Pre-Amendment 3: double-
blind, placebo-controlled treatment period followed by an open-label extension) as follows:
This study was planned to include a minimum of 96 pediatric participants aged 6 to < 17 years
who have a diagnosis of detrusor overactivity associated with a neurological condition. The
sample size was selected to provide an adequate number of participants to evaluate the safety and 
efficacy of oxybutynin chloride gel treatment in a pediatric population. Participants were
randomized in a 1:1 fashion to oxybutynin chloride gel or placebo within each stratification
level, which were based on age, weight, and sex. Estimates for the average change from baseline 
(CFB) in the percentage of catheterizations without a leaking accident as well as the standard 
deviation for this variable were taken from oxybutynin TDS in Study O03010. Assuming a 
common standard deviation of 28 for the CFB in the percentage of catheterizations without a 
leaking accident, a difference between treatment groups of 20 (assuming average for oxybutynin 
chloride gel = 25 and average for placebo = 5), and n = 48 participants per treatment group, there 
is 93% power to detect a statistically significant difference between treatment groups. Based on 
discontinuation rates from Study O03010, if we assume a 10% dropout rate, then there is 90% 
power to detect a statistically significant difference between treatment groups.
The open-label study (participants enrolled Post-Amendment 3) will include a minimum of
25 pediatric participants aged 3 to < 17 years (efforts will be made to enroll a greater number of 
participants aged 3 years to < 6 years) who have a diagnosis of detrusor overactivity associated 
with a neurological condition. This sample size is expected to provide a minimum of 10 
participants with 14 weeks of exposure.
5.2
Changes in the Conduct of the Study or Planned Analyses
At the time of writing this SAP, there were no changes in study conduct from what is described 
in the protocol and protocol amendments. Changes to planned analyses from what was described 
in the protocol are detailed in this SAP as described in Section 5.2.2 below.
5.2.1
Changes in the Conduct of the Study
Not applicable.
 
 
 


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5.2.2
Changes to Analyses Prior to Database Lock
Version
Date
Summary
1.0
24 Oct 2017
Original version
2.0
28 Mar 2022
o
Exact (Clopper-Pearson) 95% CI, Exact unconditional 95% 
CI using the score statistic, and Cochran-Mantel-Haenszel 
(CMH) was added in Table 5-2 to analyze binary urodynamic
variable (Presence (versus total absence) of involuntary 
detrusor contractions at > 15 cm H2O)
o
CFB Mixed Model was deleted from Table 5-2. All CFB 
Mixed model analyses have been replaced with CFB 
ANCOVA as reflected in Table 5-12
o
Study part was removed as a factor from the CFB ANCOVA 
models
o
Details of how urodynamic assessments will be analyzed have 
been added in Table 5-12
o
Section 5.1.1.2 was modified to clarify analysis populations 
presented in demographics tables.
o
Exact Kolmogorov-Smirnov test was added in Table 5-2 to 
compare whether distributions of efficacy endpoints between 
patients treated with oxybutynin chloride gel in the two parts 
(Pre-Amendment 3 and Post-Amendment 3) of the study are 
the same
o
Section 5.1.1.3.1 was modified to provide details on how 
efficacy endpoints will be analyzed based on whether the 
distributions of efficacy endpoints between patients treated 
with oxybutynin chloride gel in the two parts (Pre-
Amendment 3 and Post-Amendment 3) of the study were the 
same or not
o
Updated Table 5-15 definition of treatment-emergent adverse 
events in double-blind period to distinguish between 
participants who enter the 8-week open-label period from
those that do not


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6.
Data Handling and Analysis Conventions
6.1
Study Treatment Conventions
6.1.1
Analysis Days
Treatment days are defined as follows:
Table 6-1
Analysis Day Definitions
Term
Description
Treatment Day
Double-Blind
Relative to first dose date in double-blind phase if analysis date ≥ first dose date in double-
blind phase:

Day = analysis date – first dose date in double-blind phase + 1
o
Day 1 =first dose date in double-blind phase
If analysis date < first dose date in double-blind phase:

Day = analysis date – first dose date in double-blind phase
o
Day -1 = day before first dose date in double-blind phase
o
There is no Day 0
Open-Label
Relative to first dose date in open-label phase if analysis date ≥ first dose date in open-label 
phase:

Day = analysis date – first dose date in open-label phase + 1
o
Day 1 =first dose date in open-label phase
If analysis date < first dose date in open-label phase:

Day = analysis date – first dose date in open-label phase
o
Day -1 = day before first dose date in open-label phase
o
There is no Day 0
6.1.2
Missing/Incomplete Treatment End Date
If the investigator is unable to provide the treatment end date, treatment end date will be imputed 
to the last available dosing record date.
6.2
Analysis Visit Windows
6.2.1
Efficacy
The analysis visit windows for efficacy endpoints during Post-Amendment 3 open-label period 
are defined as follows:


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Table 6-2
Efficacy Analysis Visit Definitions for Pre-Amendment 3 Double-Blind Treatment 
Period
Analysis Phase
Analysis Visit (Derived)
Study Visit (CRF)
Window
Treatment
Double-Blind Period
Baseline
Visit 1/Visit 2
Treatment Day ≤ 1
Week 2
Visit 4
Treatment Day [2, 28]
Week 6
Visit 6
Treatment Day [29, X1] if patients 
enters open label period; 
Treatment Day ≥ 29 otherwise
1    X = First dose date of open label period – first dose date of double blind period + 1.
Table 6-3
Efficacy Analysis Visit Definitions for Post-Amendment 3 Open-Label Treatment 
Period
Analysis Phase
Analysis Visit (Derived)
Study Visit (eCRF)
Window
Treatment
Baseline
Visit A/Visit B
Treatment Day ≤ 1
Week 6
Visit D
Treatment Day ≥ 29of open-label 
treatment
6.2.2
Safety and Other Assessments
The analysis visit windows for safety and other assessment endpoints are defined as follows:
Table 6-4
Safety Analysis Visit Definitions for Pre-Amendment 3
Analysis Phase
Analysis Visit (Derived)
Study Visit (CRF)
Window
Treatment
Double-Blind Period
Baseline
Visit 1/ Visit 2
Treatment Day ≤ 1
Week 1
Visit 3
Treatment Day [2,  11]
Week 2
Visit 4
Treatment Day [12, 21]
Week 4
Visit 5
Treatment Day [22, 35]
Week 6
Visit 6
Treatment Day [36, X1] if patients 
enters open label period; 
Treatment Day ≥ 36 otherwise
Open-Label Period
Week 8
Visit 7
Treatment Day [2, 35] of open-
label treatment 
Week 14
Visit 8/ET
Treatment Day ≥ 36 of open-label 
treatment 
1   X = First dose date of open label period – first dose date of double blind period + 1.


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Table 6-5
Safety Analysis Visit Definitions for Post-Amendment 3 Open-Label Treatment 
Period
Analysis Phase
Analysis Visit (Derived)
Study Visit (eCRF)
Window
Treatment
Baseline
Visit A/Visit B
Treatment Day ≤ 1
Week 2
Visit C
Treatment Day [2,  28]
Week 6
Visit D
Treatment Day [29, 56]
Week 10
Visit E
Treatment Day [57, 84]
Week 14
Visit F/ET
Treatment Day ≥ 85 
The following general conventions for repeated or unscheduled assessments will apply unless 
otherwise specified:

The latest non-missing assessment within any analysis window will be flagged as the 
analysis value for any summaries by analysis visit

All postbaseline assessments will be considered for PCS categorization

All assessments will be included in respective listings
6.3
Missing/Incomplete Date Conventions
Dates may be imputed with year, month, and day values under certain scenarios:
Table 6-6
Imputation Scenarios
Complete
Scenario
Year
Month
Day
Imputable
1
Yes
Yes
Yes
Complete
2
Yes
Yes
—
Yes
3
Yes
—
Yes
No1
4
Yes
—
—
Yes
5
—
Yes
Yes
No1
6
—
Yes
—
No1
7
—
—
Yes
No1
8
—
—
—
Yes
1    Not allowed per database design.
Dates will be imputed initially toward a specified target date for imputable scenarios 2, 4, and 8, 
and adjusted against the latest reasonable dates. The initial imputed date is determined by the 
following algorithm:


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Table 6-7
Initial Imputed Date Algorithm
Available Year
Available Month (MM)
(YYYY)
Missing
< Target Month
= Target Month
> Target Month
Missing
Target Date
—
< Target Year
YYYY-12-31
YYYY-MM-LD
= Target Year
Target Date
YYYY-MM-LD
Target Date
YYYY-MM-01
> Target Year
YYYY-01-01
YYYY-MM-01
YYYY = available start date year; MM = available start date month; LD = last day of the month.
6.3.1
Missing/Incomplete AE Start Date
AE start dates will be imputed as the minimum of the following:

Initial imputed date, where target date = Treatment start date

Complete end date
6.3.2
Missing/Incomplete Medication Start Date
Medication start dates will be imputed as the minimum of the following:

Initial imputed date, where target date = Treatment start date – 1

Complete end date
6.3.3
Missing/Incomplete AE/Medication End Date
AE and medication end dates will be imputed as the minimum of the following:

Initial imputed date, where target date = Last dose date + 30

Death date
6.4
Safety Endpoint Conventions
6.4.1
Adverse Events
6.4.1.1
Missing Intensity or Relationship
If the investigator is unable to provide the actual values, the following imputations will be 
applied:
Table 6-8
Missing AE Intensity and Relationship Imputation Algorithms
Missing Value
Imputation
Timing
Intensity
Mild
Screening Period
Severe
Treatment Period
Relationship
—
Screening Period
Related
Treatment Period
 
 
 
 


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6.4.2
Clinical Laboratory Assessments
6.4.2.1
Potentially Clinically Significant Criteria
Laboratory assessments values meeting any of the following PCS low or PCS high criteria will 
be identified as PCS in the laboratory data listing:
Table 6-9
Clinical Laboratory PCS Criteria
PCS Criteria
Category
Parameter
SI Unit
PCS Low
PCS High
Chemistry
Albumin
g/L
< 0.9 × LLN
> 1.1 × ULN
Alanine aminotransferase
U/L
—
≥ 3.0 × ULN
Aspartate aminotransferase
U/L
—
≥ 3.0 × ULN
Bilirubin, total
μmol/L
—
> 1.5 × ULN
Calcium
mmol/L
< 0.9 × LLN
> 1.1 × ULN
Chloride
mmol/L
< 0.9 × LLN
> 1.1 × ULN
Creatinine
μmol/L
—
> 1.3 × ULN
Glucose, fasting
mmol/L
< 0.8 × LLN
> 1.2 × ULN
Glucose, nonfasting
mmol/L
< 0.8 × LLN
> 1.4 × ULN
Potassium
mmol/L
< 0.9 × LLN
> 1.1 × ULN
Protein, total 
g/L
< 0.9 × LLN
> 1.1 × ULN
Sodium
mmol/L
< 0.9 × LLN
> 1.1 × ULN
Hematology
Hematocrit
Ratio
< 0.9 × LLN
> 1.1 × ULN
Hemoglobin
g/L
< 0.9 × LLN
> 1.1 × ULN
Platelet count
109/L
≤ 0.5 × LLN
≥ 1.5 × ULN
Red blood cell count
1012/L
< 0.9 × LLN
> 1.1 × ULN
White blood cell count
109/L
≤ 0.7 × LLN
≥ 1.5 × ULN
Urinalysis
pH
—
< 0.9 × LLN
> 1.1 × ULN
Specific gravity
—
—
> 1.1 × ULN
LLN = lower limit of normal value; ULN = upper limit of normal value; normal value provided by laboratory.
SI = Le Système International d’Unités (International System of Units).
6.4.2.2
Continuous Descriptives and Shift Table Parameters
The following laboratory parameters will be summarized:
Table 6-10
Clinical Descriptive and Shift Table Parameters
Category
Parameters
Hematology
Platelet count 
RBC Indices:
WBC count with Differential:
RBC count
MCV
Neutrophils
Hemoglobin
MCH
Lymphocytes
Hematocrit
%Reticulocytes
Monocytes
Eosinophils
Basophils
Chemistry
BUN
Potassium
AST (SGOT)
Total bilirubin
Creatinine
Sodium
ALT (SGPT)
Total protein
Glucose [fasting or 
nonfasting will be 
indicated]
Calcium
Alkaline phosphatase


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6.4.2.3
Character Values
Character values (eg, < 5, negative) will be reviewed prior to database lock and converted to 
numeric for analysis as appropriate. These conversions will be documented in the ADaM 
specifications.
6.4.3
Vital Signs
6.4.3.1
Continuous Descriptives Parameters
The following vital sign parameters will be summarized:
Table 6-11
Vital Sign Descriptive Parameters
Parameters
Systolic BP
Respiratory rate
Weight (Screening only)
Diastolic BP
Temperature
BMI (Screening only)
Pulse rate
BP = blood pressure.
6.5
Imputed Value Listing Conventions
In general, listings will present the actual partial or missing values rather than the imputed values 
that may be used in endpoint derivation. In instances where imputed values will be presented, 
imputed values will be flagged. Actual rules will be fully defined in the table, figure, and data 
listing specification document.
 
 
-
-


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Appendix 1
Schedule of Events for Pre-Amendment 3
Note that this table is found in Appendix 1 of OG09002 Protocol Amendment 2, Schedule of 
Events (Watson Laboratories, Inc. dated 25 June 2012).