A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350636
• Other study ID #: OG05009
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2006
• Last updated: April 13, 2010
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: April 2010
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Oxybutynin topical gel
1 application daily to skin for 12 weeks

Other:
• Placebo topical gel
1 application daily to skin for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):17 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Average Number of Daily Incontinence Episodes	Average number of daily incontinence episodes at baseline	Baseline	No
Primary	Change From Baseline in Average Daily Number of Incontinence Episodes	Change from Baseline to Week 12 in average daily number of incontinence episodes	Baseline to Week 12	No
Secondary	Baseline Average Daily Urinary Frequency	Number of daily urinary voids	Baseline	No
Secondary	Change From Baseline in Average Daily Urinary Frequency	Change from baseline in average daily urinary frequency	Baseline to 12 weeks	No
Secondary	Baseline Average Urine Void Volume	Baseline average urine void volume	Baseline	No
Secondary	Change From Baseline in Average Urine Void Volume	Change from baseline to Week 12 in average urine void volume	Change from Baseline to Week 12	No

External Links

•   Drugs@FDA
•   Watson Pharma product webpage