Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
NCT ID: NCT00196404
Last Updated: 2012-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
800 participants
INTERVENTIONAL
2004-10-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
DR-3001a
4mg daily vaginally
2
DR-3001b
6 mg vaginally daily
3
Placebo
Administered vaginally to match experimental arms
Interventions
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DR-3001a
4mg daily vaginally
DR-3001b
6 mg vaginally daily
Placebo
Administered vaginally to match experimental arms
Eligibility Criteria
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Inclusion Criteria
* Using birth control or menopausal
* Willing to discontinue current medication for overactive bladder
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Duramed Research, Inc
Principal Investigators
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Medical Monitor
Role: PRINCIPAL_INVESTIGATOR
Duramed Research
Locations
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Duramed Investigational Site
Birmingham, Alabama, United States
Duramed Investigational Site
Huntsville, Alabama, United States
Duramed Investigational Site
Mobile, Alabama, United States
Duramed Research Site
Phoenix, Arizona, United States
Duramed Research Site
Tucson, Arizona, United States
Duramed Investigational Site
Little Rock, Arkansas, United States
Duramed Investigational Site
San Diego, California, United States
Duremed Research Site
San Diego, California, United States
Duramed Investigational Site
Aurora, Colorado, United States
Duramed Research Site
Colorado Springs, Colorado, United States
Duramed Investigational Site
Denver, Colorado, United States
Duramed Investigational Site
Waterbury, Connecticut, United States
Duramed Investigational Site
Aventura, Florida, United States
Duramed Research Site
Gainesville, Florida, United States
Duramed Investigational Site
Decatur, Georgia, United States
Duramed Research Site
Sandy Springs, Georgia, United States
Duramed Investigational Site
Boise, Idaho, United States
Duramed Investigational Site
Boise, Indiana, United States
Duramed Investigational Site
Evansville, Indiana, United States
Duramed Investigational Site
Fort Wayne, Indiana, United States
Duramed Investigational Site
Indianapolis, Indiana, United States
Duramed Investigational Site
Jeffersonville, Indiana, United States
Duramed Investigational Site
Meridian, Indiana, United States
Duramed Investigational Site
Shreveport, Louisiana, United States
Duramed Investigational Site
Jackson, Mississippi, United States
Duramed Investigational Site
Lebanon, New Hampshire, United States
Duramed Investigational Site
Edison, New Jersey, United States
Duramed Investigational Site
Livingston, New Jersey, United States
Duramed Investigational Site
Moorestown, New Jersey, United States
Duramed Investigational Site
Williamsville, New York, United States
Duramed Investigational Site
Portland, Oregon, United States
Duramed Investigational Site
Lancaster, Pennsylvania, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, United States
Duramed Investigational Site
Providence, Rhode Island, United States
Duramed Investigational Site
Charleston, South Carolina, United States
Duramed Investigational Site
Jackson, Tennessee, United States
Duramed Investigational Site
Memphis, Tennessee, United States
Duramed Investigational Site
Nashville, Tennessee, United States
Duramed Investigational Site
Dallas, Texas, United States
Duramed Research Site
Houston, Texas, United States
Duramed Investigational Site
San Antonio, Texas, United States
Duramed Research Site
Waco, Texas, United States
Duramed Investigational Site
Salt Lake City, Utah, United States
Duramed Investigational Site
Seattle, Washington, United States
Duramed Research Site
Tacoma, Washington, United States
Duramed Investigational Site
Milwaukee, Wisconsin, United States
Duramed Investigational Site
Vancouver, British Columbia, Canada
Duramed Investigational Site
Toronto, Ontario, Canada
Countries
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References
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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Related Links
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MedLine Plus - Urinary Incontinence
Other Identifiers
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BR-OXY-202
Identifier Type: -
Identifier Source: org_study_id