Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

Study Overview
=================
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

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

Conditions
-----------------
Overactive Detrusor, Neurogenic Bladder

Intervention / Treatment
-----------------
* Drug: Oxybutynin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxybutynin Chloride<br> | Drug: Oxybutynin<br>* 10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.<br>* Other names: Gelnique;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of catheterizations without a leaking accident. | The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary. | baseline (week 0) up to week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average volume of urine collected per catheterization (for Pre-Amendment 3 population only) | The Pre-Amendment 3 population 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 | baseline (week 0) up to week 6 | 
| Average volume of urine collected at first (morning awakening) catheterization |  | baseline (week 0) up to week 6 | 
| Average number of catheterizations per day |  | baseline (week 0) up to week 6 |