A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
Phase 3
Completed
- Conditions
- Overactive Bladder
- Interventions
- Other: Placebo topical gel
- Registration Number
- NCT00350636
- Lead Sponsor
- Watson Pharmaceuticals
- Brief Summary
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 789
Inclusion Criteria
- Females and males, 18 years of older with overactive bladder symptoms
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxybutynin topical gel Oxybutynin topical gel Oxybutynin topical gel Placebo topical gel Placebo topical gel placebo topical gel
- Primary Outcome Measures
Name Time Method Baseline Average Number of Daily Incontinence Episodes Baseline Average number of daily incontinence episodes at baseline
Change From Baseline in Average Daily Number of Incontinence Episodes Baseline to Week 12 Change from Baseline to Week 12 in average daily number of incontinence episodes
- Secondary Outcome Measures
Name Time Method Baseline Average Daily Urinary Frequency Baseline Number of daily urinary voids
Change From Baseline in Average Daily Urinary Frequency Baseline to 12 weeks Change from baseline in average daily urinary frequency
Baseline Average Urine Void Volume Baseline Baseline average urine void volume
Change From Baseline in Average Urine Void Volume Change from Baseline to Week 12 Change from baseline to Week 12 in average urine void volume