Clinical trial NCT03497039
Conditions: Pain
Sponsor: GlaxoSmithKline
Start date: 2018-07-19; Completion date: 2019-03-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the exposure of diclofenac in the plasma and in the knee joint following topical administration of DDEA gel 4 gram (g) applied twice daily for 7 days.

Detailed description:
The study will be performed in Participants diagnosed with OA of the knee who are scheduled for arthroplasty of the knee as a treatment for their OA.

Approximately fifty (50) male and female OA participants, who, at the time of screening, are ≥50 years old, will be randomized in a 2:1 ratio: two thirds will receive DDEA gel treatment and one third placebo gel.After providing informed consent to participate in the study the participants will need to forego any non-steroidal anti inflammatory drug (NSAID) or cyclooxygenase (COX)-2 treatment for at least 7 days prior to starting study treatment (Visit 2) to allow wash-out of existing therapy and thus avoiding confounding the effect of the study treatments.

There will be 4 study center visits as follows:

Visit 1 Screening visit: Day -7 (Window: Day-10 to Day-7) Visit 2 Baseline (randomization) visit: Morning of Day 1 Visit 3 Hospital admittance through to surgery and post-surgery: Evening of Day 7 through Day 8 (Surgery may be delayed by up to 7 days) Visit 4 Final visit: Day 8 to Day 10 (Between recovery and discharge)

The Participants will be provided paracetamol as rescue medication, to be used up to a total daily dose of 4 gram (g). Rescue medication will be available from the Screening Visit (Day -7) through to end of Day 7. Should the need arise for additional pain relief, the investigators will be allowed to prescribe codeine or tramadol. Postoperative analgesia will be handled according to the surgical center's pain management procedures.

Arms: arm 1: In the active treatment arm, DDEA gel will be applied topically at a dose of 4 gram (g) on 400 square centimeter (cm\^2) twice a day for 7 days to the target knee (the knee planned for arthroplasty surgery). arm 2: In the placebo control arm, placebo gel will be applied topically at a dose of 4 gram (g) on 400 square centimeter (cm\^2) twice a day for 7 days to the target knee (the knee planned for arthroplasty surgery).
Interventions: intervention 1: Diclofenac Diethylamine (DDEA) gel intervention 2: Placebo gel
Intervention descriptions: intervention 1: Diclofenac Diethylamine (DDEA) gel consists of 2.32% DDEA. DDEA gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of study treatment will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery.If surgery is delayed by up to 7 days dosing with DDEA gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study. intervention 2: Placebo gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of placebo gel will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery. If surgery is delayed by up to 7 days dosing with placebo gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study.

Protocol documents:
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SAP_001.pdf: 
Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
Property of GSK Consumer Healthcare 
Confidential 
May not be used, divulged, published or otherwise disclosed 
without the consent of GSK 
Template Version Effective: 15-Dec-2017 
Page 1 of 22 
 
 
 
 
 
STATISTICAL REPORTING AND ANALYSIS PLAN  
 
 
 
 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, 
Steady-State Pharmacokinetic and Disposition Study Characterizing 
Diclofenac’s Plasma and Knee Exposure in Osteoarthritis Subjects 
Undergoing Scheduled Arthroplasty after Treatment with Diclofenac 
Diethylamine 2.32% Gel 
 
 
 
Protocol Number: 208901  
Phase: 
Phase 1 
 
 
 
 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 2 of 22 
Document History 
 
Document 
Version Date 
Summary of Changes (New analysis or Change 
in planned analysis) 
Original Analysis Plan 
08 May 2019 
Not applicable (N/A) 
 
 
 
 
 
 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 3 of 22 
Table of contents 
Document History ............................................................................................................... 2 
Table of contents ................................................................................................................. 3 
List of tables ........................................................................................................................ 5 
List of figures ...................................................................................................................... 5 
List of Abbreviations .................................................................................................................. 6 
1 
Summary of Key Protocol Information ............................................................................... 7 
1.1 
Study Design ............................................................................................................ 7 
1.2 
Study Objectives ...................................................................................................... 8 
1.3 
Treatments ............................................................................................................... 9 
1.4 
Sample Size Calculation .......................................................................................... 9 
2 
Planned Analyses ................................................................................................................. 9 
2.1 
Interim Analysis ....................................................................................................... 9 
2.2 
Final Analyses ......................................................................................................... 9 
3 
Considerations for Data Analyses and Data Handling Conventions ................................. 10 
3.1 
Baseline Definition ................................................................................................ 10 
3.2 
Centers Pools ......................................................................................................... 10 
4 
Data Analysis ..................................................................................................................... 10 
4.1 
Populations for Analysis ........................................................................................ 10 
4.1.1 
Subject Disposition ............................................................................... 10 
4.1.2 
Protocol Deviations ............................................................................... 10 
4.1.3 
Analysis Populations ............................................................................. 11 
4.2 
Subject Demographics and Other Baseline Characteristics ................................... 12 
4.2.1 
Demographic Characteristics ................................................................ 12 
4.2.2 
General Medical History ....................................................................... 13 
4.3 
Treatments (Study Drug, Rescue Medication, other Concomitant Therapies, 
Compliance) ........................................................................................................... 13 
4.3.1 
Study Drug Compliance ........................................................................ 13 
4.3.2 
Study Drug Exposure ............................................................................ 13 
4.3.3 
Prior and Concomitant Medication ....................................................... 13 
4.3.4 
Rescue Medication ................................................................................ 16 
4.4 
Analysis of Primary Objective............................................................................... 16 
4.4.1 
Primary Endpoints ................................................................................. 16 
4.4.2 
Handling of Missing Values/Censoring/Discontinuations .................... 17 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 4 of 22 
4.5 
Analysis of Secondary Objective........................................................................... 17 
4.5.1 
Secondary Endpoints ............................................................................. 17 
4.5.2 
Handling of Missing Values/Censoring/Discontinuations .................... 17 
4.6 
Analysis of Exploratory Objectives ....................................................................... 17 
4.6.1 
Exploratory Endpoints .......................................................................... 17 
4.6.2 
Handling of Missing Values/Censoring/Discontinuations .................... 18 
4.7 
Analysis of Safety .................................................................................................. 18 
4.7.1 
Adverse Events and Serious Adverse Events ........................................ 18 
4.7.2 
Laboratory Tests .................................................................................... 19 
4.7.3 
Vital Signs ............................................................................................. 19 
4.7.4 
Findings on Physical Examination ........................................................ 19 
4.7.5 
ECG ....................................................................................................... 20 
4.8 
Analysis of Other Variables ................................................................................... 20 
4.8.1 
Diclofenac Plasma Concentrations ....................................................... 20 
4.8.2 
Handling of Missing Values/Censoring/Discontinuations .................... 20 
5 
Changes to the Protocol Defined Statistical Analysis Plan ............................................... 20 
6 
References ......................................................................................................................... 21 
 
 
 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 5 of 22 
List of tables 
Table 4-1 
Imputation rules for the start or stop date of missing or incomplete 
medications ........................................................................................... 15 
Table 5-1 
Changes to Protocol Defined Analysis Plan ......................................... 20 
 
List of figures 
Figure 1-1 
A schematic of the study design .............................................................. 8 
 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 6 of 22 
List of Abbreviations 
 
Abbreviation 
Description 
AE  
Adverse Event 
ATC 
Anatomical Therapeutic Chemical 
b.i.d.  
Twice Daily 
BDRM 
Blind Data Review Meeting 
BMI  
Body Mass Index 
COX-2  
Cyclo-oxygenase 2 
CRF  
Case Report Form 
DDEA  
Diclofenac Diethylamine 
ECG  
Electrocardiogram 
GSKDRUG 
GSK Drug Coding Dictionary 
LOQ 
Limit of Quantification 
MedDRA 
Medical Dictionary for Regulatory Activities 
N/A 
Not Applicable 
OA 
Osteoarthritis 
PP 
Per Protocol 
PP-PD 
Per Protocol Pharmacodynamic 
SOC 
System Organ Class 
TEAE 
Treatment Emergent Adverse Event 
 
 
 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 7 of 22 
The purpose of this Statistical Reporting and Analysis Plan is to describe the planned analyses 
and outputs to be included in the Clinical Study Report for Protocol 208901. 
1 
Summary of Key Protocol Information 
The purpose of this study is to evaluate the exposure of diclofenac in the plasma and in the knee 
joint following topical administration of 2.32% diclofenac diethylamine (DDEA) gel (Voltarol 
12 Hour Emulgel P 2.32% Gel in the UK, Voltaren Schmerzgel forte 23.2 mg/g gel in Germany) 
4 g applied twice daily (b.i.d.) for 7 days. 
This will be a randomized, double-blind, multi-center, placebo-controlled clinical study 
investigating the concentration of topically applied diclofenac achieved in the knee joint 
synovial tissue and synovial fluid following b.i.d dosing for seven days. 
The study will be performed in subjects diagnosed with osteoarthritis (OA) of the knee who are 
scheduled for arthroplasty of the knee as a treatment for their OA. 
1.1 
Study Design 
Approximately fifty (50) male and female OA subjects, who, at the time of screening, are ≥50 
years old, will be randomized in a 2:1 ratio: two thirds will receive DDEA 2.32% gel treatment 
and one third placebo gel. 
After providing informed consent to participate in the study the subjects will need to forego any 
NSAID or cyclo-oxygenase 2 (COX-2) treatment for at least 7 days prior to starting study 
treatment (Visit 2) in order to allow wash-out of existing therapy and thus avoiding confounding 
the effect of the study treatments. Dosing will be scheduled to commence seven days prior (at 
minimum) to the scheduled surgery and will occur twice a day following dosing instructions. If 
surgery is delayed dosing with study treatment can continue up to 14 days.  
A schematic of the study design is provided in Figure 1-1. 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 8 of 22 
Figure 1-1 
A schematic of the study design  
 
1.2 
Study Objectives 
 
Objectives 
Endpoints 
Primary Objective 
Primary Endpoint 
• To determine whether diclofenac 
penetrates into treated knee joint 
following repeated topical administration 
of diclofenac diethylamine 2.32% gel. 
• Diclofenac concentration in treated knee 
synovial tissue and synovial fluid after 7 days 
topical application of study treatment to the 
knee (12 hours after last application) 
Secondary Objectives 
Secondary Endpoints 
• To evaluate the relative exposure of 
diclofenac in the knee joint vs. plasma. 
• Ratio between diclofenac concentration in 
treated knee synovial tissue and diclofenac 
plasma concentration (sample taken during 
surgery) after 7 days topical application of 
study treatment to the knee (12 hours after 
last application) 
• Ratio between diclofenac concentration in 
treated knee synovial fluid and diclofenac 
plasma concentration (sample taken during 
surgery) after 7 days topical application of 


Diclofenac Diethylamine 2.32% Gel 
Protocol Number: 208901 
Statistical Reporting and Analysis Plan, 08 May 2019 
 
 
 
GlaxoSmithKline Consumer Healthcare Confidential 
Page 9 of 22 
Objectives 
Endpoints 
study treatment to the knee (12 hours after 
last application) 
Exploratory Objectives 
Exploratory Endpoints 
• To evaluate treatment effects upon COX-
2 inhibition in the knee joint 
• PGE2 levels in treated knee synovial tissue 
and synovial fluid after 7 days topical 
application of study treatment to the knee (12 
hours after last application) 
• To evaluate treatment effects upon 
inflammatory cytokines in the knee joint 
• IL-6 and TNFα levels in treated knee synovial 
tissue and synovial fluid after 7 days topical 
application of study treatment to the knee (12 
hours after last application) 
1.3 
Treatments 
The study includes one active treatment arm and one placebo control arm. 
In the treatment arm, DDEA 2.32% gel will be applied to the knee planned for arthroplasty 
surgery (target knee). If the subject has bilateral knee OA, the treatment will be applied to the 
knee planned for surgery only and not to the contralateral knee. A placebo control arm is 
included to facilitate bioactivity comparisons. In the placebo control arm a placebo gel will be 
applied in a similar manner as the DDEA 2.32% gel on the knee planned for surgery (target 
knee). 
1.4 
Sample Size Calculation 
A formal estimation of sample size was not carried out. The sample size selected (approximately 
30 subjects on active, 15 subjects on placebo control) for the present study is in general 
agreement with similar studies (Benito 2005, Gallelli 2013, Gallelli 2012, Alvarez-Soria 2006, 
Fowler 1983, Efe 2014) and is deemed adequate to provide information on diclofenac 
concentration(s) in treated knee synovial tissue and synovial fluid. 
Approximately 50 subjects will be randomized to account for 10% dropout and ensure evaluable 
data for 45 subjects who underwent the surgery. 
2 
Planned Analyses 
2.1 
Interim Analysis 
No interim analysis is planned. 
2.2 
Final Analyses 
The final planned primary analyses will be performed after the completion of the following 
sequential steps: 


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1. All subjects have completed the study as defined in the protocol. 
2. All required database cleaning activities have been completed and database has been 
locked. 
3 
Considerations for Data Analyses and Data Handling 
Conventions 
3.1 
Baseline Definition 
For all endpoints, the baseline value is the latest pre-dose assessment with a non-missing value.  
3.2 
Centers Pools 
This study is a multicenter study. Data will be summarized for all centers combined. Statistical 
analyses will not be adjusted for centers.  
4 
Data Analysis 
Data analysis will be performed by PPD. The statistical analysis software used will be SAS 
version 9.4 in a WINDOWS environment.   
Prior to database closure a Blind Data Review Meeting (BDRM) will be conducted in which 
various aspects of the trial will be discussed and agreed.  
4.1 
Populations for Analysis 
Tables described in this section will be produced for all randomized subjects.   
4.1.1 Subject Disposition 
Subject disposition will be summarized as the number and percentage of subjects who complete 
the study, with the number who discontinue broken down by reason for discontinuation (Table 
14.1.1). Subject disposition including date of informed consent, date of first and last dose, 
completion status (Yes/No), completion or termination date and reason for discontinuation will 
be listed in Listing 16.2.1.1 by treatment group.  
A listing of screen failures including date of screening and reason(s) for screen failure will be 
provided (Listing 16.2.1.2). 
4.1.2 Protocol Deviations 
All protocol deviations (both significant and non-significant) will be entered and tracked in PPD 
Clinical Trial Management System (CTMS) by the study team throughout the conduct of the 
study in accordance with PPD’s Study Deviation Rules Document.  
Significant protocol deviations that would exclude subjects from the Per Protocol (PP) 
population may include (but are not limited to) the following: 


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• 
Major deviations in synovial tissue and synovial fluid sampling  
• 
Subjects with poor compliance with study treatment 
• 
Subjects taking prohibited medication or treatment during the study which is felt to affect 
the assessment of diclofenac concentration in synovial tissue and synovial fluid samples 
Significant protocol deviations that would exclude subjects from the Per Protocol 
Pharmacodynamic (PP-PD) population may include (but are not limited to) the following: 
• 
Major deviations in synovial tissue and synovial fluid sampling 
• 
Subjects with poor compliance with study treatment 
• 
Subjects taking NSAIDs or/and corticosteroids administered between screening and 
synovial samples collection 
• 
Subjects taking other prohibited medications between screening and synovial samples 
collection which is felt to affect the assessment of pharmacodynamic biomarker 
Data will be reviewed prior to closure of the database to ensure all significant deviations are 
captured and categorised.  
Final list of significant protocol deviations leading to exclusion from the PP population (These 
were considered as major protocol deviations in protocol) and from the PP-PD population will 
also be determined by the study team.  
The number and percentage of subjects with any significant protocol deviations and with each 
type of significant protocol deviations will be presented by treatment (Table 14.1.2) and listed 
in Listing 16.2.2.1.  Any non-significant protocol deviations will be listed similarly (Listing 
16.2.2.2).   
4.1.3 Analysis Populations 
  
Population 
Definition / Criteria 
Analyses Evaluated 
Safety 
• Comprised of all subjects who are 
randomized and have received at least 
one dose of investigational product. 
• This population will be based on the 
treatment the subject actually received. 
• Safety 
 
Analysable 
• Comprised of all randomized subjects 
included in the safety population, who 
completed the surgery and have evaluable 
synovial tissue or synovial fluid sample. 
• This population will be based on the 
treatment the subject actually received. 
• Primary, Secondary 
and Exploratory 
 


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Population 
Definition / Criteria 
Analyses Evaluated 
Per Protocol (PP) 
• Comprised of all randomized subjects from 
the analysable population who do not have 
any significant protocol deviations that 
could confound the interpretation of 
primary analyses conducted on the 
analysable population. 
• Protocol deviations that would exclude 
subjects from the PP population are 
defined in Section 4.1.2 (Protocol 
Deviations). 
• This population will be based on the 
treatment the subject actually received. 
• None 
Per Protocol 
Pharmacodynamic 
(PP-PD) 
• Comprised of all randomized subjects from 
the analysable population who do not have 
any significant protocol deviations that 
could confound the interpretation of 
exploratory analyses for 
pharmacodynamic biomarkers (i.e. PGE2, 
IL-6 and TNFα). 
• Protocol deviations that would exclude 
subjects from the PP-PD population are 
defined in Section 4.1.2 (Protocol 
Deviations). 
• This population will be based on the 
treatment the subject actually received. 
• Exploratory  
 
The numbers of subjects included in each of the analysis populations will be presented (Table 
14.1.1).  Subjects excluded from any of the analysis populations will be listed in Listing 
16.2.3.1, with the reason for exclusion.   
4.2 
Subject Demographics and Other Baseline Characteristics 
4.2.1 Demographic Characteristics 
Categorical demographic variable includes sex. This variable will be summarized by the 
number and percentage of subjects with each relevant characteristic in each treatment group.  
Body Mass Index (BMI) will be calculated as weight (kg)/ [height (m)]2.  Age, weight, height 
and BMI will be summarized by the mean, standard deviation, median, minimum and maximum 


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values in each treatment group.  All demographic information will be tabulated for the safety 
population (Table 14.1.3) and for the analysable population (Table 14.1.4). All demographic 
information will also be listed for safety population (Listing 16.2.4.1). 
4.2.2 General Medical History 
Medical history will be listed for the safety population by subject, with start date and end date 
or ongoing at the start of treatment with study drug (Listing 16.2.4.2). 
4.3 
Treatments (Study Drug, Rescue Medication, other Concomitant 
Therapies, Compliance) 
Compliance data will be summarized for the analysable population. Exposure and other 
medications will be summarized on the safety population. 
4.3.1 Study Drug Compliance  
Study drug compliance is evaluated by the total number of applications and percentage of 
scheduled applications made. Percentage of scheduled applications made is defined as the 
number of applications made divided by the number of applications planned. The study drug 
will start to be applied on the day of randomization (Day 1) and continue to be applied twice 
daily until and including the day before surgery. The number of applications planned will be 
calculated as 2*(date of last application-date of first application +1). Both compliance variables 
will be summarized descriptively for the analysable population. In addition, number and 
percentage of subjects with a minimum of 12 applications will be also presented (Table 
14.2.1.1). Study drug accountability (Listing 16.2.5.1) and study drug administration (Listing 
16.2.5.2) will also be listed for the safety population.  
4.3.2 Study Drug Exposure 
Study drug exposure will be summarized descriptively by treatment group for the Safety 
population, including the following summaries: total number of applications and total weight 
of gel used (Table 14.3.1). 
4.3.3 Prior and Concomitant Medication 
Any medications taken by subject within 90 days before the screening visit (Visit 1) and up to 
the last study visit (Visit 4) during the study will be recorded in the case report form (CRF). 
All medications will be coded using the GSK Drug coding dictionary (GSKDRUG), which will 
be updated whenever available throughout the life of the study.  
For purposes of analysis, prior medications are defined as any medications with a stop date that 
is prior to the initial study drug dosing date (Day 1) and concomitant medications are defined 
as any medications with a start date on or after the initial study drug dosing date (Day 1) or any 
medications with a start date prior to the initial study drug dosing date and a stop date after the 
initial study dosing date. 


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For medications with partial start or stop dates, the partial dates will be imputed according to 
Table 4-1 and then will be categorized as prior medication or concomitant medication according 
to the definitions. Medications with completely missing dates will be included in the 
concomitant medication summary. 
Imputation rules for the start or stop date of missing or incomplete medications are presented 
in Table 4-1. 
 
 


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Table 4-1 
Imputation rules for the start or stop date of missing or incomplete 
medications 
 
 
Missing 
Imputation 
Exception 
Start date 
(concomitant 
medication) 
Day 
01 
Default to Study Day 1 if 
an event starts the same 
year and month as Day 1 
and the stop date contains a 
full date and the stop date 
is later than Day 1; 
Otherwise If the stop date 
is prior to Day 1, default to 
1 day prior to the stop date 
Day/Month 
01Jan 
Default to Study Day 1 if 
an event started the same 
year as Day1 and the stop 
date contains a full date 
and the stop date is later 
than Day 1; Otherwise If 
the stop date is prior to 
Day 1, default to 1 day 
prior to the stop date 
Day/Month/Year No imputation 
Assume start prior to study 
entry. 
Stop date 
(concomitant 
medication) 
Day 
Last day of the 
month 
Default to the End of Study 
Date if the concomitant 
medication stopped the 
same year and month as 
the End of Study Date. 
Day/Month 
31DEC 
Default to the End of Study 
Date if the concomitant 
medication stopped the 
same year as the End of 
Study Date. 
Day/Month/Year No imputation 
Assume stops after study 
end. 
Tables and listings described in this section will be presented for the safety population. The 
prior and concomitant medications listing will include the preferred term, indication, a flag 
indication of prior or concomitant, single dose, frequency, unit, route, start date, and end date 
or ongoing at final visit (Listing 16.2.5.7). The significant non-drug therapies listing will 


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include the name of non-drug therapy, a flag indication of prior or concomitant, start date, and 
end date or ongoing at final visit (Listing 16.2.5.8). 
Concomitant medications will be reported by GSK-Drug Anatomical Therapeutic Chemical 
(ATC) classification level 1 (Body System) and ingredient (Table 14.3.2). Drugs that are 
composed of a combination of ingredients will be displayed according to the ATC 
classifications of the ingredients, not of the combination. 
4.3.4 
Rescue Medication 
Rescue medications used during the study treatment period (number of subjects that used 
paracetamol, number of days on paracetamol, percentage of days on paracetamol and total dose 
of paracetamol taken) will be presented by treatment group for the analysable population (Table 
14.2.1.2). This summary will only include those subjects who used rescue medications during 
the study treatment period.  
By-subject listing of all rescue medications, used before start of the study treatment and during 
the study treatment, will be produced for the safety population (Listing 16.2.5.3). 
4.4 
Analysis of Primary Objective  
The primary objective of this study is to determine whether diclofenac penetrates into the treated 
knee joint following repeated topical administration of diclofenac diethylamine 2.32% gel. 
4.4.1 Primary Endpoints 
4.4.1.1 
Primary Endpoints Definition 
The primary endpoints are diclofenac concentrations in treated knee synovial tissue and 
synovial fluid after 7 days topical application of study treatment to the knee (12 hours after last 
application). 
4.4.1.2 
Statistical Hypothesis, Model, and Method of Analysis 
The success criterion of this study is that diclofenac can be detected within the treated knee 
synovial tissue or synovial fluid after 7 days treatment. 
Synovial tissue and synovial fluid diclofenac concentrations will be summarized descriptively 
by treatment group in both the arithmetic and the logarithmic scale (Table 14.2.2.1 and Table 
14.2.3.1). The tables will present the proportion of subjects with values above the limit of 
quantification (LOQ) with its two-sided 95% confidence interval estimated by Wilson score 
interval. The mean, SD, min, P10, Q1, median, Q3, P90, max will be calculated after replacing 
values below the LOQ by LOQ/2 for treatment group and by 0 for placebo group. The geometric 
mean will also be calculated for treatment group with a two-sided 95% confidence interval 
assuming data on the logarithmic scale are normally distributed. Boxplots for study treatment 
group will be produced on the original data (Figure 14.2.1 and Figure 14.2.3). There is no formal 
hypothesis testing to be performed. 


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The analyses will be performed on the analysable population. 
4.4.2 
Handling of Missing Values/Censoring/Discontinuations 
Missing data will not be imputed. Values that are below the limit of quantification (LOQ) will 
be replaced by LOQ/2 for treatment group and be replaced by 0 for placebo group.  
4.5 
Analysis of Secondary Objective 
The secondary objective is to evaluate the relative exposure of diclofenac in the knee joint vs. 
plasma. 
4.5.1 
Secondary Endpoints 
The secondary endpoints are  
• 
Ratio between diclofenac concentration in treated knee synovial tissue and diclofenac 
plasma concentration (sample taken during surgery) after 7 days topical application 
of study treatment to the knee (12 hours after last application) 
• 
Ratio between diclofenac concentration in treated knee synovial fluid and diclofenac 
plasma concentration (sample taken during surgery) after 7 days topical application 
of study treatment to the knee (12 hours after last application) 
Following the same approach as for the primary endpoints, the ratios between diclofenac 
concentration in synovial tissue / fluid and diclofenac plasma concentration (last sample taken 
during surgery) will be summarized descriptively by treatment group in both the arithmetic and 
the logarithmic scale. Geometric means will be calculated with two-sided 95% confidence 
intervals (Table 14.2.4.1 and Table 14.2.5.1). Boxplots for study treatment group will be 
produced (Figure 14.2.5 and Figure 14.2.7). The analyses will be performed on the analysable 
population. 
4.5.2 
Handling of Missing Values/Censoring/Discontinuations 
Missing data will not be imputed. For diclofenac concentrations in treated knee synovial tissue 
or synovial fluid that are below the limit of quantification (LOQ), refer to Section 4.4.2 for 
imputation. For diclofenac plasma concentrations that are below the limit of quantification 
(LOQ), refer to Section 4.8.2 for imputation. For placebo group the ratios will be set as missing.  
4.6 
Analysis of Exploratory Objectives 
The exploratory objectives are  
• To evaluate treatment effects upon COX-2 inhibition in the knee joint 
• To evaluate treatment effects upon inflammatory cytokines in the knee joint 
4.6.1 
Exploratory Endpoints 
The exploratory endpoints are 


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• PGE2 levels in treated knee synovial tissue and synovial fluid after 7 days topical 
administration to the knee (12 hours after last application) 
• IL-6 and TNFα levels in treated knee synovial tissue and synovial fluid after 7 days 
topical administration to the knee (12 hours after last application) 
The success criteria for exploratory objectives are  
• diclofenac reduces PGE2 levels in treated knee synovial tissue or synovial fluid after 7 
days topical administration to the knee compared to placebo gel 
• diclofenac reduces levels of inflammatory cytokines i.e. TNFα and/or IL-6 associated 
with OA in treated knee synovial tissue or synovial fluid after 7 days topical 
administration to the knee compared to placebo gel 
PGE2 and inflammatory cytokines levels will be summarized descriptively in both the 
arithmetic and the logarithmic scale (Table 14.2.6 - Table 14.2.11). The mean, SD, min, P10, 
Q1, median, Q3, P90 and max will be summarized. 
For each endpoint, the success criterion will be addressed by a two-sided test for superiority at 
level alpha=0.05 in an exploratory manner. Log-transformed mean levels will be compared 
between treatment groups using an analysis of variance including treatment as a fixed effect. 
The two-sided 95% confidence interval for the ratio of geometric means on the original scale 
will be derived by back-transforming the confidence interval for the difference between 
treatment groups on the log-transformed scale obtained from the analysis.  
The analyses will be performed on the analysable population. 
The analyses will be repeated for the PP-PD (Per Protocol Pharmacodynamic) Population 
(Table 14.2.13 - Table 14.2.18). 
4.6.2 
Handling of Missing Values/Censoring/Discontinuations 
Missing data will not be imputed. Values that are below the limit of quantification (LOQ) will 
be replaced by LOQ/2.  
4.7 
Analysis of Safety 
4.7.1 
Adverse Events and Serious Adverse Events 
Adverse events (AEs) will be summarized (Table 14.3.1.1) by presenting, for each treatment 
group, the number and percentage of subjects having any AE, any Treatment Emergent adverse 
events (TEAE), any serious TEAE, any study drug-related TEAE, any study drug-related 
serious TEAE, any TEAE leading to treatment discontinuation or study discontinuation, or any 
AE leading to death. TEAE is defined as an AE that starts on or after the date of first study 
treatment. For an AE with an incomplete start date where the day is missing while the year and 
month are present and the same as the date of first study treatment administration, the date of 
first study treatment will be assumed to be the AE start date. 


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TEAEs will be summarized by presenting, for each treatment group, the number and percentage 
of subjects having any TEAE, any TEAE in each MedDRA primary system organ class (SOC) 
and having each individual TEAE (using MedDRA preferred term).  
This will be done separately for all TEAEs by SOC/Preferred term (Table 14.3.1.2) and for 
TEAEs that are suspected to be drug-related by SOC/Preferred term (Table 14.3.1.4). All 
TEAEs will also be tabulated in corresponding fashion by SOC/Preferred term/Intensity (Table 
14.3.1.3 and Table 14.3.1.5). Any other information collected (e.g. action taken, duration, 
outcome, seriousness) will be listed as appropriate. 
Additionally, all adverse events will be listed (listing 16.2.7.1). 
Deaths occurring during treatment (if any) will be listed by treatment, including the date and 
study day of death, and the principal cause of death (listing 14.3.2.1).  Non-fatal serious AEs 
and TEAEs leading to study treatment discontinuation will be listed (listing 14.3.2.2 and Listing 
14.3.2.3).   
4.7.2 
Laboratory Tests 
Chemistry and hematology results at Screening, Visit 3 and at Visit 4 will be summarized by 
the mean, standard deviation, median, minimum and maximum values in each treatment group 
(Tables 14.3.3). Shift tables (between baseline and Visit 3, between Visit 3 and Visit 4) will 
also be presented (Table 14.3.4 and Table 14.3.5). Laboratory normal ranges will be listed in 
Listing 16.2.8.1 and all laboratory (chemistry, hematology and urinalysis) test results will be 
listed in Listings 16.2.8.2 – 16.2.8.4. 
Note: Laboratory tests were performed by the local hospital laboratories. Normal ranges 
provided prior to study start were recorded in the eCRF. During the study the normal ranges 
had shifted slightly for some of the tests at some of the local laboratories, but the shifted normal 
ranges were not recorded in the eCRF. The shift tables will be based on the normal ranges 
provided prior to study start.  
4.7.3 
Vital Signs 
Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body 
temperature) recorded at Visit 3 and changes in vital signs from Visit 2 (Baseline) to Visit 3 
will be summarized by the mean, standard deviation, median, minimum and maximum values 
in each treatment group (Tables 14.3.6). Vital signs at each assessment will also be listed 
(Listing 16.2.9.1). 
4.7.4 
Findings on Physical Examination 
A full physical examination will include head, ears, eyes, nose, mouth, skin, heart and lung 
examinations, lymph nodes, gastrointestinal, musculoskeletal, vascular and neurological 
systems.  


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The findings on the physical examination performed at Visit 1-Visit 4 will be listed (Listing 
16.2.9.2). 
4.7.5 
ECG 
The findings on the electrocardiogram (ECGs) performed at Visit 1, Visit 3 and Visit 4 will be 
listed (Listing 16.2.9.3). 
4.8 
Analysis of Other Variables 
4.8.1 
Diclofenac Plasma Concentrations 
Diclofenac plasma concentrations will be summarized (Table 14.2.12) on the analysable 
population by calculating the mean, standard deviation, median, minimum and maximum for 
the following timepoints: Visit 2 (baseline), Visit 3 (pre-dose), Visit 3 (sample taken between 
last application and surgery), Visit 3 (last sample taken during surgery). Mean of diclofenac 
plasma concentrations will also be plotted by visits (Figure 14.2.9).  
4.8.2 
Handling of Missing Values/Censoring/Discontinuations 
Missing data will not be imputed. For diclofenac plasma concentrations in active treatment 
group, values that are below the limit of quantification (LOQ) will be replaced by LOQ/2 for 
post-baseline visits and be replaced by 0 for baseline visit. For diclofenac plasma concentrations 
in placebo group, values that are below the limit of quantification (LOQ) will be replaced by 0 
for all visits. 
5 
Changes to the Protocol Defined Statistical Analysis Plan 
Any changes from the originally planned statistical analysis specified in the protocol are 
outlined in Table 5-1. 
Table 5-1 
Changes to Protocol Defined Analysis Plan 
 
Protocol 
Reporting & Analysis Plan 
Statistical Analysis section 
Statistical Analysis Plan 
Rationale for Changes 
• No analysis was 
planned for Per 
Protocol 
Pharmacodynamic 
population in protocol 
• Analyses for Per Protocol 
Pharmacodynamic 
population are added for 
exploratory analyses. 
• Per Protocol 
Pharmacodynamic 
population analyses are 
added for sensitivity 
analyses. 
• Values that are below 
the limit of 
quantification (LOQ) 
• For diclofenac 
concentrations in treated 
knee synovial tissue or 
synovial fluid after 7 days 
• For active treatment 
group, we don’t expect 
to see diclofenac 
concentrations before 


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Protocol 
Reporting & Analysis Plan 
Statistical Analysis section 
Statistical Analysis Plan 
Rationale for Changes 
will be replaced by 
LOQ/2. 
of topical application, 
values that are below the 
limit of quantification 
(LOQ) will be replaced by 
LOQ/2 for active treatment 
group and be replaced by 0 
for placebo group. 
• For diclofenac plasma 
concentrations in active 
treatment group, values that 
are below the limit of 
quantification (LOQ) will 
be replaced by LOQ/2 for 
post-baseline visits and be 
replaced by 0 for baseline 
visits. For diclofenac 
plasma concentrations in 
placebo group, values that 
are below the limit of 
quantification (LOQ) will 
be replaced by 0 for all 
visits. 
• For PGE2, IL-6 and TNFα, 
values that are below the 
limit of quantification 
(LOQ) will be replaced by 
LOQ/2. 
first application of 
study treatment. For 
placebo group, we 
don’t expect to see 
diclofenac 
concentrations at any 
visit.    
6 
References 
1. [Álvarez-Soria, M.A., Largo, R., Santillana, J., Sánchez-Pernaute, O., Calvo, E., 
Hernandez, M., Egido, J. and Herrero-Beaumont, G., 2006]. Long term NSAID treatment 
inhibits COX-2 synthesis in the knee synovial membrane of subjects with osteoarthritis: 
differential proinflammatory cytokine profile between celecoxib and aceclofenac. Annals 
of the rheumatic diseases, 65(8), pp.998-1005. 
 
2. [Benito, M.J., Veale, D.J., FitzGerald, O., van den Berg, W.B. and Bresnihan, B., 2005]. 
Synovial tissue inflammation in early and late osteoarthritis. Annals of the rheumatic 
diseases, 64(9), pp.1263-1267. 
 


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3. [Efe, T., Sagnak, E., Roessler, P.P., Getgood, A., Patzer, T., Fuchs-Winkelmann, S., 
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trial. Knee Surgery, Sports Traumatology, Arthroscopy, 22(2), pp.345-350. 
 
4. [Fowler, P.D., Shadforth, M.F., Crook, P.R. and John, V.A., 1983]. Plasma and synovial 
fluid concentrations of diclofenac sodium and its major hydroxylated metabolites during 
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5. [Gallelli, L., Galasso, O., Falcone, D., Southworth, S., Greco, M., Ventura, V., Romualdi, 
P., Corigliano, A., Terracciano, R., Savino, R. and Gulletta, E., 2013]. The effects of 
nonsteroidal anti-inflammatory drugs on clinical outcomes, synovial fluid cytokine 
concentration and signal transduction pathways in knee osteoarthritis. A randomized open 
label trial. Osteoarthritis and Cartilage, 21(9), pp.1400-1408. 
 
6. [Gallelli, L., Galasso, O., Urzino, A., Saccà, S., Falcone, D., Palleria, C., Longo, P., 
Corigliano, A., Terracciano, R., Savino, R. and Gasparini, G., 2012]. Characteristics and 
clinical implications of the pharmacokinetic profile of ibuprofen in subjects with knee 
osteoarthritis. Clinical drug investigation, 32(12), pp.827-833.