MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.

Overactive Bladder Clinical Trial

Official title:

A Randomized, Double-blind, Placebo and Active-controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174798
• Other study ID #: ACT5190
• Secondary ID: SSR240600C
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 1, 2012
• Start date: May 2005
• Est. completion date: May 2006

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.

Description:

Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)

• Bladder capacity </= 300 mL by cystometry

Exclusion Criteria:

• History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder

• Current urinary tract infection

• Neurological bladder dysfunction

• Treatment with drugs that may interfere with CYP3A4 metabolic function

• History of stress urinary incontinence

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Drug:
• SSR240600C
once daily
• Placebo
oral
• Tolterodine
once daily

Locations

Country	Name	City	State
United States	Atlanta Women's Research Institute	Alpharetta	Georgia
United States	Mount Vernon Clinical Research	Atlanta	Georgia
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Soapstone Center for Education & Clinical Research	Decatur	Georgia
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Urology of Indiana	Greenwood	Indiana
United States	Metropolitan Urology	Jeffersonville	Indiana
United States	Rockhill Medical Plaza	Kansas City	Missouri
United States	Hudson Valley Urology Center	Kingston	New York
United States	Daniel Laury	Medford	Oregon
United States	Miami Research Associates	Miami	Florida
United States	Midwest Research SpecialistsSt. Michael's Hospital	Milwaukee	Wisconsin
United States	Philadelphia Women's Research	Philadelphia	Pennsylvania
United States	Hope Research LLC	Phoenix	Arizona
United States	Clinical Trials Research Services	Pittsburgh	Pennsylvania
United States	Hudson Valley Urology	Poughkeepsie	New York
United States	University Urological Research Institute	Providence	Rhode Island
United States	Medical Center for Clinical Research	San Diego	California
United States	Tacoma Women's Specialists Research	Tacoma	Washington
United States	Southeastern Research Group	Tallahassee	Florida
United States	Research Tuscon	Tuscon	Arizona
United States	Connecticut Clinical Research Center, Urology Specialists	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
Secondary	Change from baseline to end of treatment in:maximum detrusor pressure,volume ar first desire to void,volume at first unstable contraction,micturition frequence,urgency episodes,nocturia episodes,incontinence episodes,HRQOL and overall improvement