NCT00196404

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DRUG	DR-3001a	4mg daily vaginally
DRUG	DR-3001b	6 mg vaginally daily
OTHER	Placebo	Administered vaginally to match experimental arms

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-20
• Last updated: 2012-08-20

Locations

48 sites across 2 countries: United States, Canada