Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension

Watson Pharmaceuticals0 sites789 target enrollmentJune 2006

Overview

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

May 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Watson Pharmaceuticals

•Treatable conditions that may cause urinary incontinence
•Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
•The use of concomitant drugs that would confound the efficacy evaluation.
•The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Intervention: Oxybutynin topical gel

placebo topical gel

Intervention: Placebo topical gel

Baseline Average Number of Daily Incontinence Episodes

Time Frame: Baseline

Average number of daily incontinence episodes at baseline

Change From Baseline in Average Daily Number of Incontinence Episodes

Time Frame: Baseline to Week 12

Change from Baseline to Week 12 in average daily number of incontinence episodes

Baseline Average Daily Urinary Frequency(Baseline)
Change From Baseline in Average Daily Urinary Frequency(Baseline to 12 weeks)
Baseline Average Urine Void Volume(Baseline)
Change From Baseline in Average Urine Void Volume(Change from Baseline to Week 12)