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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-05-31

Brief Summary

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To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.

Detailed Description

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Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

SSR240600C

Group Type EXPERIMENTAL

SSR240600C

Intervention Type DRUG

once daily

Tolterodine

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

once daily

Interventions

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SSR240600C

once daily

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Tolterodine

once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)
* Bladder capacity \</= 300 mL by cystometry

Exclusion Criteria

* History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
* Current urinary tract infection
* Neurological bladder dysfunction
* Treatment with drugs that may interfere with CYP3A4 metabolic function
* History of stress urinary incontinence
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Research Tuscon

Tuscon, Arizona, United States

Site Status

Medical Center for Clinical Research

San Diego, California, United States

Site Status

Genitourinary Surgical Consultants

Denver, Colorado, United States

Site Status

Connecticut Clinical Research Center, Urology Specialists

Waterbury, Connecticut, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Southeastern Research Group

Tallahassee, Florida, United States

Site Status

Atlanta Women's Research Institute

Alpharetta, Georgia, United States

Site Status

Mount Vernon Clinical Research

Atlanta, Georgia, United States

Site Status

Soapstone Center for Education & Clinical Research

Decatur, Georgia, United States

Site Status

Urology of Indiana

Greenwood, Indiana, United States

Site Status

Metropolitan Urology

Jeffersonville, Indiana, United States

Site Status

Rockhill Medical Plaza

Kansas City, Missouri, United States

Site Status

Hudson Valley Urology Center

Kingston, New York, United States

Site Status

Hudson Valley Urology

Poughkeepsie, New York, United States

Site Status

Daniel Laury

Medford, Oregon, United States

Site Status

Philadelphia Women's Research

Philadelphia, Pennsylvania, United States

Site Status

Clinical Trials Research Services

Pittsburgh, Pennsylvania, United States

Site Status

University Urological Research Institute

Providence, Rhode Island, United States

Site Status

Advanced Research Associates

Corpus Christi, Texas, United States

Site Status

Tacoma Women's Specialists Research

Tacoma, Washington, United States

Site Status

Midwest Research SpecialistsSt. Michael's Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

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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