SSR240600C Treatment in Women With Overactive Bladder - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00564226

Purpose

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	Intervention	Phase
Overactive Bladder	Drug: SSR240600C Drug: tolterodine Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Tolterodine Tolterodine tartrate SSR240600

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change from baseline in the number of micturitions per 24 hours [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

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 [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Safety of SSR240600 [ Time Frame: at week 12 ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Enrollment:	345
Study Start Date:	November 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dose level 1	Drug: SSR240600C oral administration
2: Experimental dose level 2	Drug: SSR240600C oral administration
3: Experimental dose level 3	Drug: SSR240600C oral administration
4: Active Comparator	Drug: tolterodine oral administration
5: Placebo Comparator	Drug: placebo oral administration

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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 patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564226

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI6271, EudraCT 2007-004126-24
Study First Received:	November 26, 2007
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00564226 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Sanofi-Aventis:

urge urinary incontinence

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Urination Disorders
Physiological Effects of Drugs
Urinary Bladder Diseases
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Urinary Incontinence
Urinary Incontinence, Urge
Tolterodine

ClinicalTrials.gov processed this record on November 30, 2009