MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
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)
2 other identifiers
interventional
118
1 country
22
Brief Summary
To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2005
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFebruary 2, 2012
February 1, 2012
1 year
September 13, 2005
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
Secondary Outcomes (1)
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
Study Arms (3)
Placebo
PLACEBO COMPARATORSSR240600C
EXPERIMENTALTolterodine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)
- Bladder capacity \</= 300 mL by cystometry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (22)
Hope Research LLC
Phoenix, Arizona, 85032, United States
Research Tuscon
Tuscon, Arizona, 85712, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Connecticut Clinical Research Center, Urology Specialists
Waterbury, Connecticut, 06708, United States
Miami Research Associates
Miami, Florida, 33143, United States
Southeastern Research Group
Tallahassee, Florida, 32308, United States
Atlanta Women's Research Institute
Alpharetta, Georgia, 30005, United States
Mount Vernon Clinical Research
Atlanta, Georgia, 30328, United States
Soapstone Center for Education & Clinical Research
Decatur, Georgia, 30034, United States
Urology of Indiana
Greenwood, Indiana, 46143, United States
Metropolitan Urology
Jeffersonville, Indiana, 47130, United States
Rockhill Medical Plaza
Kansas City, Missouri, 64131, United States
Hudson Valley Urology Center
Kingston, New York, 12401, United States
Hudson Valley Urology
Poughkeepsie, New York, 12601, United States
Daniel Laury
Medford, Oregon, 97504, United States
Philadelphia Women's Research
Philadelphia, Pennsylvania, 19114, United States
Clinical Trials Research Services
Pittsburgh, Pennsylvania, 15206, United States
University Urological Research Institute
Providence, Rhode Island, 02904, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Tacoma Women's Specialists Research
Tacoma, Washington, 98405, United States
Midwest Research SpecialistsSt. Michael's Hospital
Milwaukee, Wisconsin, 53209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
May 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
February 2, 2012
Record last verified: 2012-02