A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

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 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duramed Research

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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