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Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Urinary Incontinence Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Clinical Trial Summary

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

Clinical Trial Description

This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00196404
Study type Interventional
Source Teva Pharmaceutical Industries
Contact
Status Completed
Phase Phase 2
Start date October 2004
Completion date December 2006
View Details
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