BILADY: SSR240600C Treatment in Women With Overactive Bladder

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00564226

Collaborator

(none)

345

Enrollment

Locations

Arms

Duration (Months)

49.3

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: SSR240600C Drug: tolterodine Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

345 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo	Drug: placebo oral administration

Outcome Measures

Primary Outcome Measures

Change from baseline in the number of micturitions per 24 hours [at week 12]

Secondary Outcome Measures

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 [at week 12]
Safety of SSR240600C [at week 12]
Quality of life [at week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Aministrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Laval	Quebec	Canada
3	Sanofi-Aventis Administrative Office	Praha		Czech Republic
4	Sanofi-Aventis Administrative Office	Paris		France
5	Sanofi-Aventis Administrative Office	Berlin		Germany
6	Sanofi-Aventis Administrative Office	Gouda		Netherlands
7	Sanofi-Aventis Administrative Office	Porto Salvo		Portugal

Sponsors and Collaborators

Sanofi

Investigators

Study Director: ICD CSD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT00564226

Other Study ID Numbers:

DRI6271
EudraCT 2007-004126-24

First Posted:

Nov 27, 2007

Last Update Posted:

May 26, 2016

Last Verified:

Apr 1, 2016

Keywords provided by Sanofi

urge urinary incontinence

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Tolterodine Tartrate

Study Results

No Results Posted as of May 26, 2016