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

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: DR-3001; Drug: Placebo

• Registration Number: NCT00685113
• Lead Sponsor: Duramed Research

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-28
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2011-06-08
• Disposition First Submitted QC: 2011-06-08
• Disposition First Posted: 2011-06-22
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DR-3001	-
2	DR-3001	-
3	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in total weekly number of incontinence (urge and stress)episodes	Baseline to end-of-treamtent (Week 12/Early withdrawal)

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with no incontinence episodes recorded in the final 3-day diary	Final 3-day diary
Adverse events (AEs) reported by subjects or identified by the investigator	Basline to end-of-treatment (Week 12/Early Withdrawal)
Change in average daily urinary frequency and average void volume	Baseline to end-of-treamtent (Week 12/Early withdrawal)
3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question	Baseline to end-of-treatment (Week 12/Early Withdrawal)

Trial Locations

Locations (3)

Duramed Investigational Site; 🇨🇦 Thunder Bay, Ontario, Canada

Duramed Investigation Site; 🇺🇸 Decatur, Georgia, United States

Duramed Investigatinal Site; 🇨🇦 Vancouver, British Columbia, Canada