MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
NCT ID: NCT00174798
Last Updated: 2012-02-02
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
118 participants
INTERVENTIONAL
2005-05-31
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
oral
SSR240600C
SSR240600C
once daily
Tolterodine
Tolterodine
once daily
Interventions
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SSR240600C
once daily
Placebo
oral
Tolterodine
once daily
Eligibility Criteria
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Inclusion Criteria
* Bladder capacity \</= 300 mL by cystometry
Exclusion Criteria
* Current urinary tract infection
* Neurological bladder dysfunction
* Treatment with drugs that may interfere with CYP3A4 metabolic function
* History of stress urinary incontinence
18 Years
75 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Hope Research LLC
Phoenix, Arizona, United States
Research Tuscon
Tuscon, Arizona, United States
Medical Center for Clinical Research
San Diego, California, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Connecticut Clinical Research Center, Urology Specialists
Waterbury, Connecticut, United States
Miami Research Associates
Miami, Florida, United States
Southeastern Research Group
Tallahassee, Florida, United States
Atlanta Women's Research Institute
Alpharetta, Georgia, United States
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Soapstone Center for Education & Clinical Research
Decatur, Georgia, United States
Urology of Indiana
Greenwood, Indiana, United States
Metropolitan Urology
Jeffersonville, Indiana, United States
Rockhill Medical Plaza
Kansas City, Missouri, United States
Hudson Valley Urology Center
Kingston, New York, United States
Hudson Valley Urology
Poughkeepsie, New York, United States
Daniel Laury
Medford, Oregon, United States
Philadelphia Women's Research
Philadelphia, Pennsylvania, United States
Clinical Trials Research Services
Pittsburgh, Pennsylvania, United States
University Urological Research Institute
Providence, Rhode Island, United States
Advanced Research Associates
Corpus Christi, Texas, United States
Tacoma Women's Specialists Research
Tacoma, Washington, United States
Midwest Research SpecialistsSt. Michael's Hospital
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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SSR240600C
Identifier Type: -
Identifier Source: secondary_id
ACT5190
Identifier Type: -
Identifier Source: org_study_id
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