Status:
COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder
Lead Sponsor:
Duramed Research
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a ...
Eligibility Criteria
Inclusion
- Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months
- Able to distinguish between stress and urge incontinence
- During the Screening Period able to demonstrate the presence of overactive bladder with urge incontinence based on diary entries
- Others as dictated by FDA-approved protocol
Exclusion
- Stress incontinence, continuous incontinence or overflow urinary incontinence
- Chronic illness, neurological dysfunction or injury that could cause incontinence
- Pregnant, breastfeeding, or gave birth in the last 6 months
- Others as dictated by FDA-approved protocol
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
1104 Patients enrolled
Trial Details
Trial ID
NCT00685113
Start Date
May 1 2008
End Date
March 1 2010
Last Update
July 20 2016
Active Locations (84)
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1
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
2
Duramed Investigational Site
Mobile, Alabama, United States, 36608
3
Duramed Investigational Site
Montgomery, Alabama, United States, 36116
4
Duramed Investigational Site
Phoenix, Arizona, United States, 85015