SSR240600C Treatment in Women With Overactive Bladder | NCT00564226

Studies
SSR240600C Treatment in Women With Overactive Bladder

NCT00564226

Sponsor

Sanofi

Status

Completed

Last Update Posted

May 26, 2016Estimated

Enrollment

345Actual

Phase

Phase 2

Conditions

Overactive Bladder

Interventions

SSR240600C
tolterodine
placebo

Countries

United States
Canada
Czechia
France
Germany
Netherlands
Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2007-004126-24

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Nov 26, 2007

First Submission Date that Met QC Criteria

Nov 26, 2007

First Posted Date

Nov 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 27, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 27, 2016

Certification/Extension First Posted Date

May 26, 2016Estimated

Last Update Submitted Date

Apr 27, 2016

Last Update Posted Date

May 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

345Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SSR240600C Dose Level 1	Experimental		Drug: SSR240600C
SSR240600C Dose Level 2	Experimental		Drug: SSR240600C
SSR240600C Dose Level 3	Experimental	dose level 3	Drug: SSR240600C
Tolterodine	Active Comparator		Drug: tolterodine
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSR240600C	Drug	oral administration	SSR240600C Dose Level 1 SSR240600C Dose Level 2 SSR240600C Dose Level 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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		at week 12
Safety of SSR240600C		at week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 participant's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Aministrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive
D053202	Urinary Incontinence, Urge

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068737	Tolterodine Tartrate

Ancestor Terms

ID	Term
D010665	Phenylpropanolamine
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided