An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
NCT00138749
Last updated date
ABOUT THIS STUDY
A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of
stress urinary incontinence.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Stress Urinary Incontinence
Sex
Female
Age
18-65 years
Inclusion Criteria
Show details
- Clinically significant stress urinary incontinence
Exclusion Criteria
Show details
- History or evidence of any relevant confounding urological or neurological disease
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Stress Urinary IncontinenceAn 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
NCT00138749
- Anchorage, Alaska
- Sun City, Arizona
- Tucson, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Atherton, California
- Carmichael, California
- Laguna Woods, California
- Murrieta, California
- Newport Beach, California
- Sacramento, California
- San Diego, California
- Tarzana, California
- Temecula, California
- Torrance, California
- Vista, California
- Aurora, Colorado
- Denver, Colorado
- Denver, Colorado
- Wheat Ridge, Colorado
- New London, Connecticut
- Waterbury, Connecticut
- Aventura, Florida
- New Port Richey, Florida
- Panama City, Florida
- Panama City, Florida
- Pembroke Pines, Florida
- Port Richey, Florida
- West Palm Beach, Florida
- Alpharetta, Georgia
- Coeur D Alene, Idaho
- Arlington Heights, Illinois
- Chicago, Illinois
- Melrose Park, Illinois
- Greenwood, Indiana
- Indianapolis, Indiana
- Des Moines, Iowa
- Louisville, Kentucky
- Shreveport, Louisiana
- Greenbelt, Maryland
- Watertown, Massachusetts
- Jackson, Mississippi
- Jackson, Mississippi
- Liberty, Missouri
- North Kansas City, Missouri
- Omaha, Nebraska
- Henderson, Nevada
- Edison, New Jersey
- West Orange, New Jersey
- Albuquerque, New Mexico
- Albany, New York
- Garden City, New York
- Garden City, New York
- Mineola, New York
- Poughkeepsie, New York
- Burlington, North Carolina
- Charlotte, North Carolina
- Concord, North Carolina
- Fayetteville, North Carolina
- Winston-salem, North Carolina
- Cincinnati, Ohio
- Bethany, Oklahoma
- Eugene, Oregon
- Eugene, Oregon
- Medford, Oregon
- Portland, Oregon
- Colmar, Pennsylvania
- Lancaster, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Sellersville, Pennsylvania
- Sewickley, Pennsylvania
- Providence, Rhode Island
- Charleston, South Carolina
- Columbia, South Carolina
- Greer, South Carolina
- Myrtle Beach, South Carolina
- Knoxville, Tennessee
- Knoxville, Tennessee
- Corpus Christi, Texas
- Corsicana, Texas
- Houston, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Sandy, Utah
- Sandy, Utah
- West Jordan, Utah
- Virginia Beach, Virginia
- Seattle, Washington
- Surrey, British Columbia
- Victoria, British Columbia
- Kitchener, Ontario
- Oakville, Ontario
- Montreal, Quebec
- Pointe-Claire, Quebec
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence. | |||
Official Title ICMJE | An 8-Week, Multi-Centre,Randomised Double-Blind, Placebo Controlled, Parallel Group Study To Evaluate The Efficacy,Toleration And Safety Of (+)- [S,S]- Reboxetine In The Treatment Of Stress Urinary Incontinence (SUI) In Women. | |||
Brief Summary | A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Urinary Incontinence, Stress | |||
Intervention ICMJE | Drug: SS-RBX | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 402 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2006 | |||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00138749 | |||
Other Study ID Numbers ICMJE | A6061023 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |