A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks...
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”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: May 2007
Intervention(s) in this Clinical Trial
- Drug: Oxybutynin topical gel
- 1 application daily to skin for 12 weeks
- Other: Placebo topical gel
- 1 application daily to skin for 12 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Oxybutynin topical gel
- Oxybutynin topical gel
- Placebo Comparator: Placebo topical gel
- placebo topical gel
Outcome Measures for this Clinical Trial
Primary Measures
- Baseline Average Number of Daily Incontinence Episodes
- Time Frame: Baseline
Safety Issue?: No
- Time Frame: Baseline
- Change From Baseline in Average Daily Number of Incontinence Episodes
- Time Frame: Baseline to Week 12
Safety Issue?: No
- Time Frame: Baseline to Week 12
Secondary Measures
- Baseline Average Daily Urinary Frequency
- Time Frame: Baseline
Safety Issue?: No
- Time Frame: Baseline
- Change From Baseline in Average Daily Urinary Frequency
- Time Frame: Baseline to 12 weeks
Safety Issue?: No
- Time Frame: Baseline to 12 weeks
- Baseline Average Urine Void Volume
- Time Frame: Baseline
Safety Issue?: No
- Time Frame: Baseline
- Change From Baseline in Average Urine Void Volume
- Time Frame: Change from Baseline to Week 12
Safety Issue?: No
- Time Frame: Change from Baseline to Week 12
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 Investigator Information
Lead Investigator: Watson Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Kim Caramelli, MS Study Director Watson Pharmaceuticals
Related Publications
Citations Reporting Results
Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. Epub 2009 Feb 23.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00350636
