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SSR240600C

Phase 2

Overactive Bladder | Small molecule | Nephrology |Sanofi|Last Updated: May 26, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment463

FDA Designations

No designations recorded

Clinical trial landscape

SSR240600C · 2 trials · 1 indication

Phase 2 2
NCT00564226SSR240600C Treatment in Women With Overactive BladderOveractive Bladder
COMPLETED345 Analytics
NCT00174798MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.Overactive Bladder
COMPLETED118 Analytics
PHASE2COMPLETED
SSR240600C Treatment in Women With Overactive Bladder
Overactive BladderUnlock trial analytics
PHASE2COMPLETED
MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
Overactive BladderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the number of micturitions per 24 hours
at week 12
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SSR240600C Dose Level 1EXPERIMENTAL -
SSR240600C Dose Level 2EXPERIMENTAL -
SSR240600C Dose Level 3EXPERIMENTALdose level 3
TolterodineACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
SSR240600CEXPERIMENTAL -

Interventions

NameTypeDescription
SSR240600CDRUGoral administration
tolterodineDRUGoral administration
placeboDRUGoral administration
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites7

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) * Cu...

Countries:United StatesCanadaCzechiaFranceGermanyNetherlandsPortugal
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Frequently asked questions about SSR240600C

What is SSR240600C used for?

SSR240600C is an investigational small molecule being developed by Sanofi for the treatment of overactive bladder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in female patients with overactive bladder or urge urinary incontinence.

Who makes SSR240600C?

SSR240600C is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical trials for overactive bladder, and it remains an investigational compound that has not yet received regulatory approval.

What phase is SSR240600C in?

SSR240600C is in Phase 2 clinical development. Two Phase 2 trials have been completed, both of which were randomized, double-blind, and placebo-controlled studies in female patients with overactive bladder. The drug is investigational and has not been approved by the FDA or other regulatory agencies.

What clinical trials is SSR240600C in?

SSR240600C has been studied in two completed Phase 2 clinical trials. The first, NCT00174798, enrolled 118 female patients in the United States. The second, NCT00564226, enrolled 345 female patients across the United States, Canada, Czechia, France, Germany, Netherlands, and Portugal. Both trials were randomized, double-blind, and placebo-controlled.

Is SSR240600C the same as MILADY?

SSR240600C is the drug studied in the MILADY trial, which is the clinical trial identified as NCT00174798. The trial was titled 'MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.' SSR240600C is the investigational compound evaluated in this study.