Urinary Incontinence, Stress Clinical Trial
Official title:
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.
| Verified date | April 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.
| Status | Completed |
| Enrollment | 402 |
| Est. completion date | August 2006 |
| Est. primary completion date | August 2006 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Clinically significant stress urinary incontinence Exclusion Criteria: - History or evidence of any relevant confounding urological or neurological disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Kitchener | Ontario |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Oakville | Ontario |
| Canada | Pfizer Investigational Site | Pointe-Claire | Quebec |
| Canada | Pfizer Investigational Site | Surrey | British Columbia |
| Canada | Pfizer Investigational Site | Victoria | British Columbia |
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Alpharetta | Georgia |
| United States | Pfizer Investigational Site | Anchorage | Alaska |
| United States | Pfizer Investigational Site | Arlington Heights | Illinois |
| United States | Pfizer Investigational Site | Atherton | California |
| United States | Pfizer Investigational Site | Aurora | Colorado |
| United States | Pfizer Investigational Site | Aventura | Florida |
| United States | Pfizer Investigational Site | Bethany | Oklahoma |
| United States | Pfizer Investigational Site | Burlington | North Carolina |
| United States | Pfizer Investigational Site | Carmichael | California |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Coeur D Alene | Idaho |
| United States | Pfizer Investigational Site | Colmar | Pennsylvania |
| United States | Pfizer Investigational Site | Columbia | South Carolina |
| United States | Pfizer Investigational Site | Concord | North Carolina |
| United States | Pfizer Investigational Site | Corpus Christi | Texas |
| United States | Pfizer Investigational Site | Corsicana | Texas |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Edison | New Jersey |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Fayetteville | North Carolina |
| United States | Pfizer Investigational Site | Garden City | New York |
| United States | Pfizer Investigational Site | Garden City | New York |
| United States | Pfizer Investigational Site | Greenbelt | Maryland |
| United States | Pfizer Investigational Site | Greenwood | Indiana |
| United States | Pfizer Investigational Site | Greer | South Carolina |
| United States | Pfizer Investigational Site | Henderson | Nevada |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Knoxville | Tennessee |
| United States | Pfizer Investigational Site | Knoxville | Tennessee |
| United States | Pfizer Investigational Site | Laguna Woods | California |
| United States | Pfizer Investigational Site | Lancaster | Pennsylvania |
| United States | Pfizer Investigational Site | Liberty | Missouri |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Medford | Oregon |
| United States | Pfizer Investigational Site | Melrose Park | Illinois |
| United States | Pfizer Investigational Site | Mineola | New York |
| United States | Pfizer Investigational Site | Murrieta | California |
| United States | Pfizer Investigational Site | Myrtle Beach | South Carolina |
| United States | Pfizer Investigational Site | New London | Connecticut |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | Newport Beach | California |
| United States | Pfizer Investigational Site | North Kansas City | Missouri |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Panama City | Florida |
| United States | Pfizer Investigational Site | Panama City | Florida |
| United States | Pfizer Investigational Site | Pembroke Pines | Florida |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | Port Richey | Florida |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Poughkeepsie | New York |
| United States | Pfizer Investigational Site | Providence | Rhode Island |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Sandy | Utah |
| United States | Pfizer Investigational Site | Sandy | Utah |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Sellersville | Pennsylvania |
| United States | Pfizer Investigational Site | Sewickley | Pennsylvania |
| United States | Pfizer Investigational Site | Shreveport | Louisiana |
| United States | Pfizer Investigational Site | Sun City | Arizona |
| United States | Pfizer Investigational Site | Tarzana | California |
| United States | Pfizer Investigational Site | Temecula | California |
| United States | Pfizer Investigational Site | Torrance | California |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | Vista | California |
| United States | Pfizer Investigational Site | Waterbury | Connecticut |
| United States | Pfizer Investigational Site | Watertown | Massachusetts |
| United States | Pfizer Investigational Site | West Jordan | Utah |
| United States | Pfizer Investigational Site | West Orange | New Jersey |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | Wheat Ridge | Colorado |
| United States | Pfizer Investigational Site | Winston-salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI. | |||
| Secondary | To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX. |
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