Clinical trial NCT00174798: MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: Cystometry NK1 Antagonist SSR240600C
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research LLC
state: Arizona
city: Tuscon
country: United States
facility: Research Tuscon
state: Arizona
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Waterbury
country: United States
facility: Connecticut Clinical Research Center, Urology Specialists
state: Connecticut
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Research Group
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Women's Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Decatur
country: United States
facility: Soapstone Center for Education & Clinical Research
state: Georgia
city: Greenwood
country: United States
facility: Urology of Indiana
state: Indiana
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Kansas City
country: United States
facility: Rockhill Medical Plaza
state: Missouri
city: Kingston
country: United States
facility: Hudson Valley Urology Center
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology
state: New York
city: Medford
country: United States
facility: Daniel Laury
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Women's Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services
state: Pennsylvania
city: Providence
country: United States
facility: University Urological Research Institute
state: Rhode Island
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Tacoma
country: United States
facility: Tacoma Women's Specialists Research
state: Washington
city: Milwaukee
country: United States
facility: Midwest Research SpecialistsSt. Michael's Hospital
state: Wisconsin
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: