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

Tracking Information

First Received Date ^ICMJE

May 23, 2008

Last Updated Date

October 15, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in total weekly number of incontinence (urge and stress)episodes [ Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00685113 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Doses of DR-3001 Versus Placebo in Women With Overactive Bladder

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Overactive Bladder

Intervention ^ICMJE

Drug: DR-3001
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1161

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00685113

Responsible Party

Duramed Research, Inc, Duramed Research, Inc

Study ID Numbers ^ICMJE

DR-OXY-301

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Duramed Research Protocol Chair

Duramed Research, Inc.

Information Provided By

Duramed Research

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP