NCT00564226|CompletedPhase 2DMC

SSR240600C Treatment in Women With Overactive Bladder

BILADY

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

Sanofi ClinicalTrials.gov

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2 other identifiers

DRI6271EudraCT 2007-004126-24

Study Type

interventional

Target

345

Locations

7 countries

Sites

Timeline

RegisteredNov 2007

StartedNov 2007

CompletionFeb 2009

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

345

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2007

Shorter than P25 for phase_2

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

November 1, 2007

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

November 26, 2007

Last Update Submit

April 27, 2016

Conditions

Overactive Bladder

Keywords

urge urinary incontinence

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

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

Study Arms (5)

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

SSR240600CDRUG

oral administration

SSR240600C Dose Level 1SSR240600C Dose Level 2SSR240600C Dose Level 3

tolterodineDRUG

oral administration

Tolterodine

placeboDRUG

oral administration

Placebo

Eligibility Criteria

Age18 Years - 70 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of overactive bladder

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sanofilead