Back to resultsMILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SSR240600C
Placebo
Tolterodine
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Cystometry NK1 Antagonist SSR240600C
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
Sites / Locations
- Hope Research LLC
- Research Tuscon
- Medical Center for Clinical Research
- Genitourinary Surgical Consultants
- Connecticut Clinical Research Center, Urology Specialists
- Miami Research Associates
- Southeastern Research Group
- Atlanta Women's Research Institute
- Mount Vernon Clinical Research
- Soapstone Center for Education & Clinical Research
- Urology of Indiana
- Metropolitan Urology
- Rockhill Medical Plaza
- Hudson Valley Urology Center
- Hudson Valley Urology
- Daniel Laury
- Philadelphia Women's Research
- Clinical Trials Research Services
- University Urological Research Institute
- Advanced Research Associates
- Tacoma Women's Specialists Research
- Midwest Research SpecialistsSt. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Placebo
SSR240600C
Tolterodine
Arm Description
Outcomes
Primary Outcome Measures
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174798
Brief Title
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
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Cystometry NK1 Antagonist SSR240600C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
SSR240600C
Arm Type
Experimental
Arm Title
Tolterodine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SSR240600C
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Hope Research LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Research Tuscon
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Connecticut Clinical Research Center, Urology Specialists
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Southeastern Research Group
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Atlanta Women's Research Institute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Soapstone Center for Education & Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Urology of Indiana
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Rockhill Medical Plaza
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Hudson Valley Urology Center
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Hudson Valley Urology
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Daniel Laury
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Philadelphia Women's Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Clinical Trials Research Services
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Advanced Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Tacoma Women's Specialists Research
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Midwest Research SpecialistsSt. Michael's Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
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