Clinical trial NCT01192568: Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Official 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Detrusor
Neurogenic Bladder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 52
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study was initiated as a double-blind, placebo-controlled study with an open-label extension and was amended (in Protocol Amendment 3) to continue to enroll subjects under only open-label treatment.
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 3 years to \< 17 years
* Neurogenic bladder
* Neurological condition
* CIC

Exclusion Criteria:

* Have anatomical bladder abnormalities
* Sensitivity to anticholinergics
* Bladder augmentation

Primary outcomes:
measure: Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6
timeFrame: Baseline (Week 0) up to Week 6
Secondary outcomes:
measure: Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6
timeFrame: Baseline (Week 0) up to week 6
measure: Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6
timeFrame: Baseline (Week 0) up to Week 6
measure: Change From Baseline in Average Number of Catheterizations Per Day at Week 6
timeFrame: Baseline (Week 0) up to Week 6
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University /ID# 236889
state: California
city: Orange
country: United States
facility: Child Hosp of Orange County,CA /ID# 237517
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado - Aurora /ID# 237620
state: Colorado
city: Augusta
country: United States
facility: Augusta University Medical Center /ID# 238188
state: Georgia
city: Jackson
country: United States
facility: University of Mississippi Medical Center /ID# 238065
state: Mississippi
city: Albany
country: United States
facility: Albany Medical College /ID# 236880
state: New York
city: Durham
country: United States
facility: Duke University /ID# 237494
state: North Carolina
city: Portland
country: United States
facility: Duplicate_Oregon Health & Science University /ID# 234354
state: Oregon
city: Fort Worth
country: United States
facility: Cook Children's Med. Center /ID# 237538
state: Texas
city: Norfolk
country: United States
facility: Child Hosp of the King's Dtr's /ID# 237799
state: Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15.