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

Phase 2

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: Placebo; Drug: DR-3001a; Drug: DR-3001b

• Registration Number: NCT00196404
• Lead Sponsor: Duramed Research

Brief 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

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-17
• Last Update Posted: 2012-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

• Diagnosis of overactive bladder and incontinence for at least 6 months
• Using birth control or menopausal
• Willing to discontinue current medication for overactive bladder

Exclusion Criteria

• Pregnant or given birth in the last 6 months
• Three or more urinary tract infections a year
• Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
• History of bladder cancer, ulcerative colitis or severe constipation
• Any contraindication to vaginal delivery systems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
1	DR-3001a	-
2	DR-3001b	-

Primary Outcome Measures

Name	Time	Method
Change in the total weekly number of incontinence episodes	Baseline to Treatment Week 12/Premature Discontinuation

Secondary Outcome Measures

Name	Time	Method
Average daily urinary frequency	Baseline to Treatment Week 12/Premature Discontinuation
Average void volume	Baseline to Treatment Week 12/Premature Discontinuation
Average severity of urgency	Baseline to Treatment Week 12/Premature Discontinuation
Proportion of patients with no incontinence episodes	Baseline to Treatment Week 12/Premature Discontinuation

Trial Locations

Locations (3)

Duramed Investigational Site; 🇨🇦 Toronto, Ontario, Canada

Duramed Research Site; 🇺🇸 Tacoma, Washington, United States

Duremed Research Site; 🇺🇸 San Diego, California, United States