MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.

February 1, 2012 updated by: Sanofi

A Randomized, Double-blind, Placebo and Active-controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Hope Research LLC
      • Tuscon, Arizona, United States, 85712
        • Research Tuscon
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Connecticut Clinical Research Center, Urology Specialists
    • Florida
      • Miami, Florida, United States, 33143
        • Miami Research Associates
      • Tallahassee, Florida, United States, 32308
        • Southeastern Research Group
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Atlanta Women's Research Institute
      • Atlanta, Georgia, United States, 30328
        • Mount Vernon Clinical Research
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Education & Clinical Research
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Urology of Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Metropolitan Urology
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Rockhill Medical Plaza
    • New York
      • Kingston, New York, United States, 12401
        • Hudson Valley Urology Center
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology
    • Oregon
      • Medford, Oregon, United States, 97504
        • Daniel Laury
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Philadelphia Women's Research
      • Pittsburgh, Pennsylvania, United States, 15206
        • Clinical Trials Research Services
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Urological Research Institute
    • Texas
      • Corpus Christi, Texas, United States, 78414
        • Advanced Research Associates
    • Washington
      • Tacoma, Washington, United States, 98405
        • Tacoma Women's Specialists Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Midwest Research SpecialistsSt. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
oral
EXPERIMENTAL: SSR240600C
Drug: SSR240600C
once daily
ACTIVE_COMPARATOR: Tolterodine
Drug: Tolterodine
once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.

Secondary Outcome Measures

Outcome Measure
Change from baseline to end of treatment in:maximum detrusor pressure,volume ar first desire to void,volume at first unstable contraction,micturition frequence,urgency episodes,nocturia episodes,incontinence episodes,HRQOL and overall improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT5190
  • SSR240600C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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