Status:
COMPLETED
MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
Lead Sponsor:
Sanofi
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 SSR240600...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00174798
Start Date
May 1 2005
End Date
May 1 2006
Last Update
February 2 2012
Active Locations (22)
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1
Hope Research LLC
Phoenix, Arizona, United States, 85032
2
Research Tuscon
Tuscon, Arizona, United States, 85712
3
Medical Center for Clinical Research
San Diego, California, United States, 92108
4
Genitourinary Surgical Consultants
Denver, Colorado, United States, 80220