NCT00350636CompletedPhase 3
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 enrollmentStarted: June 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 789
- Primary Endpoint
- Baseline Average Number of Daily Incontinence Episodes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Oxybutynin topical gel
Experimental
Oxybutynin topical gel
Intervention: Oxybutynin topical gel (Drug)
Placebo topical gel
Placebo Comparator
placebo topical gel
Intervention: Placebo topical gel (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
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