SSR240600C Treatment in Women With Overactive Bladder

NCT ID: NCT00564226

Last Updated: 2016-05-26

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

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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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SSR240600C Dose Level 1

Group Type EXPERIMENTAL

SSR240600C

Intervention Type DRUG

oral administration

SSR240600C Dose Level 2

Group Type EXPERIMENTAL

SSR240600C

Intervention Type DRUG

oral administration

SSR240600C Dose Level 3

dose level 3

Group Type EXPERIMENTAL

SSR240600C

Intervention Type DRUG

oral administration

Tolterodine

Group Type ACTIVE_COMPARATOR

tolterodine

Intervention Type DRUG

oral administration

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration

Interventions

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SSR240600C

oral administration

Intervention Type DRUG

tolterodine

oral administration

Intervention Type DRUG

placebo

oral administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Aministrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Laval, Quebec, Canada

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

Site Status

Countries

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United States Canada Czechia France Germany Netherlands Portugal

Other Identifiers

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EudraCT 2007-004126-24

Identifier Type: -

Identifier Source: secondary_id

DRI6271

Identifier Type: -

Identifier Source: org_study_id

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