Clinical trial NCT00138749: An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence, Stress
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 402
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Clinically significant stress urinary incontinence

Exclusion Criteria:

* History or evidence of any relevant confounding urological or neurological disease

Primary outcomes:
measure: Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI.
Secondary outcomes:
measure: To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX.
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Sun City
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Atherton
country: United States
facility: Pfizer Investigational Site
state: California
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Woods
country: United States
facility: Pfizer Investigational Site
state: California
city: Murrieta
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Tarzana
country: United States
facility: Pfizer Investigational Site
state: California
city: Temecula
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New London
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Panama City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Panama City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Coeur D Alene
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Arlington Heights
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Melrose Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Greenwood
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Greenbelt
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Liberty
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: North Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Edison
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: West Orange
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Concord
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Colmar
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sewickley
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corsicana
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: