drugset / Trial / NCT00685113

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

NCT00685113 ↗

Phase 3 Completed 1104 enrolled Duramed Research
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-05
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject DR-3001 Unknown 4 mg Other
Subject DR-3001 Unknown 6 mg Other

Indications