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NCT00196404 Clinical Trial

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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00196404
Other study ID # BR-OXY-202
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated August 17, 2012
Start date October 2004
Est. completion date December 2006

Study information
Verified date August 2012
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Duramed Investigational Site Toronto Ontario
Canada Duramed Investigational Site Vancouver British Columbia
United States Duramed Investigational Site Aurora Colorado
United States Duramed Investigational Site Aventura Florida
United States Duramed Investigational Site Birmingham Alabama
United States Duramed Investigational Site Boise Idaho
United States Duramed Investigational Site Boise Indiana
United States Duramed Investigational Site Charleston South Carolina
United States Duramed Research Site Colorado Springs Colorado
United States Duramed Investigational Site Dallas Texas
United States Duramed Investigational Site Decatur Georgia
United States Duramed Investigational Site Denver Colorado
United States Duramed Investigational Site Edison New Jersey
United States Duramed Investigational Site Evansville Indiana
United States Duramed Investigational Site Fort Wayne Indiana
United States Duramed Research Site Gainesville Florida
United States Duramed Research Site Houston Texas
United States Duramed Investigational Site Huntsville Alabama
United States Duramed Investigational Site Indianapolis Indiana
United States Duramed Investigational Site Jackson Mississippi
United States Duramed Investigational Site Jackson Tennessee
United States Duramed Investigational Site Jeffersonville Indiana
United States Duramed Investigational Site Lancaster Pennsylvania
United States Duramed Investigational Site Lebanon New Hampshire
United States Duramed Investigational Site Little Rock Arkansas
United States Duramed Investigational Site Livingston New Jersey
United States Duramed Investigational Site Memphis Tennessee
United States Duramed Investigational Site Meridian Indiana
United States Duramed Investigational Site Milwaukee Wisconsin
United States Duramed Investigational Site Mobile Alabama
United States Duramed Investigational Site Moorestown New Jersey
United States Duramed Investigational Site Nashville Tennessee
United States Duramed Investigational Site Philadelphia Pennsylvania
United States Duramed Research Site Phoenix Arizona
United States Duramed Investigational Site Portland Oregon
United States Duramed Investigational Site Providence Rhode Island
United States Duramed Investigational Site Salt Lake City Utah
United States Duramed Investigational Site San Antonio Texas
United States Duramed Investigational Site San Diego California
United States Duremed Research Site San Diego California
United States Duramed Research Site Sandy Springs Georgia
United States Duramed Investigational Site Seattle Washington
United States Duramed Investigational Site Shreveport Louisiana
United States Duramed Research Site Tacoma Washington
United States Duramed Research Site Tucson Arizona
United States Duramed Research Site Waco Texas
United States Duramed Investigational Site Waterbury Connecticut
United States Duramed Investigational Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Duramed Research

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the total weekly number of incontinence episodes Baseline to Treatment Week 12/Premature Discontinuation No
Secondary Average daily urinary frequency Baseline to Treatment Week 12/Premature Discontinuation No
Secondary Proportion of patients with no incontinence episodes Baseline to Treatment Week 12/Premature Discontinuation No
Secondary Average void volume Baseline to Treatment Week 12/Premature Discontinuation No
Secondary Average severity of urgency Baseline to Treatment Week 12/Premature Discontinuation No
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