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

Duramed Research

Status and phase

Completed

Phase 3

Conditions

Overactive Bladder

Treatments

Drug: DR-3001

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00685113

DR-OXY-301

Details and patient eligibility

About

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.

Enrollment

1,104 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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