Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
Lead Sponsor:
Duramed Research
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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 approx...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00196404
Start Date
October 1 2004
End Date
December 1 2006
Last Update
August 20 2012
Active Locations (48)
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1
Duramed Investigational Site
Birmingham, Alabama, United States, 35209
2
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
3
Duramed Investigational Site
Mobile, Alabama, United States, 36608
4
Duramed Research Site
Phoenix, Arizona, United States, 85015