A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks...
Date First Received: July 10, 2006
Last Updated: December 17, 2007
Verified by: Watson Pharmaceuticals, December 2007
Clinical Trial Phase: Phase 3 | Start Date: June 2006
Overall Status: Completed
Estimated Enrollment: 789
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: oxybutynin
- 1 application daily for 12 weeks
- Other: placebo
- 1 application daily for 12 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Oxybutynin topical gel
- Placebo Comparator: 2
- placebo topical gel
Outcome Measures for this Clinical Trial
Primary Measures
- incontinence episodes
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- frequency and void volume
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Watson Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Kim Caramelli, MS Study Director Watson Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350636
Study ID Number: OG05009
ClinicalTrials.gov Identifier: NCT00350636
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
