Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00196404

First received: September 13, 2005

Last updated: August 17, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

August 17, 2012

Start Date ^ICMJE

October 2004

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in the total weekly number of incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in the total weekly number of incontinence episodes

Change History

Complete list of historical versions of study NCT00196404 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Average daily urinary frequency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
Proportion of patients with no incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
Average void volume [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
Average severity of urgency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Average daily urinary frequency
Proportion of patients with no incontinence episodes
Average void volume
Average severity of urgency

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Official Title ^ICMJE

A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Brief Summary

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

Detailed Description

This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Urinary Incontinence

Intervention ^ICMJE

Drug: DR-3001a
4mg daily vaginally
Drug: DR-3001b
6 mg vaginally daily
Other: Placebo
Administered vaginally to match experimental arms

Study Arm (s)

Experimental: 1
Intervention: Drug: DR-3001a
Experimental: 2
Intervention: Drug: DR-3001b
Placebo Comparator: 3
Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

800

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of overactive bladder and incontinence for at least 6 months
Using birth control or menopausal
Willing to discontinue current medication for overactive bladder

Exclusion Criteria:

Pregnant or given birth in the last 6 months
Three or more urinary tract infections a year
Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
History of bladder cancer, ulcerative colitis or severe constipation
Any contraindication to vaginal delivery systems

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00196404

Other Study ID Numbers ^ICMJE

BR-OXY-202

Has Data Monitoring Committee

Responsible Party

Duramed Protocol Chair, Duramed Research, Inc

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Medical Monitor

Duramed Research

Information Provided By

Teva Pharmaceutical Industries

Verification Date

August 2012

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

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