SSR240600C Treatment in Women With Overactive Bladder (BILADY)

April 27, 2016 updated by: Sanofi

A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence

The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

345

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

  • Canada
    • Quebec
      • Laval, Quebec, Canada
        • Sanofi-Aventis Administrative Office
  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • Portugal
      • Porto Salvo, Portugal
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Aministrative Office

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of overactive bladder

Exclusion Criteria:

  • Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history
  • Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence)
  • Current Urinary Tract Infection (UTI) or frequent UTIs
  • Urinary retention or other evidence of poor detrusor function
  • Pain during voiding or bladder pain without voiding
  • History of radiation cystitis or history of pelvic irradiation
  • History of interstitial cystitis or bladder related pain syndrome

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
oral administration
Experimental: SSR240600C Dose Level 1
Drug: SSR240600C
oral administration
Experimental: SSR240600C Dose Level 2
Drug: SSR240600C
oral administration
Experimental: SSR240600C Dose Level 3
dose level 3
Drug: SSR240600C
oral administration
Active Comparator: Tolterodine
Drug: tolterodine
oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the number of micturitions per 24 hours
Time Frame: at week 12
at week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void
Time Frame: at week 12
at week 12
Safety of SSR240600C
Time Frame: at week 12
at week 12
Quality of life
Time Frame: at week 12
at week 12

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

November 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 27, 2007

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI6271
  • EudraCT 2007-004126-24

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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