An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.

April 6, 2011 updated by: Pfizer

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

402

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V-1N1
        • Pfizer Investigational Site
      • Victoria, British Columbia, Canada, V8T5G1
        • Pfizer Investigational Site
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N4
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3S 1Z1
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Pfizer Investigational Site
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712-5803
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Atherton, California, United States, 94027
        • Pfizer Investigational Site
      • Carmichael, California, United States, 95608
        • Pfizer Investigational Site
      • Laguna Woods, California, United States, 92653
        • Pfizer Investigational Site
      • Murrieta, California, United States, 92562
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95825
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • Tarzana, California, United States, 91356
        • Pfizer Investigational Site
      • Temecula, California, United States, 92591
        • Pfizer Investigational Site
      • Torrance, California, United States, 90505
        • Pfizer Investigational Site
      • Vista, California, United States, 92084
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80210
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • Pfizer Investigational Site
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • Panama City, Florida, United States, 32405
        • Pfizer Investigational Site
      • Panama City, Florida, United States, 32407
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Pfizer Investigational Site
      • Port Richey, Florida, United States, 34668
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Pfizer Investigational Site
    • Idaho
      • Coeur D Alene, Idaho, United States, 83814
        • Pfizer Investigational Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60616
        • Pfizer Investigational Site
      • Melrose Park, Illinois, United States, 60160
        • Pfizer Investigational Site
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Pfizer Investigational Site
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
      • Jackson, Mississippi, United States, 39216
        • Pfizer Investigational Site
    • Missouri
      • Liberty, Missouri, United States, 64068
        • Pfizer Investigational Site
      • North Kansas City, Missouri, United States, 64116
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Pfizer Investigational Site
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Pfizer Investigational Site
      • West Orange, New Jersey, United States, 07052
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Pfizer Investigational Site
      • Garden City, New York, United States, 11530
        • Pfizer Investigational Site
      • Garden City, New York, United States, 11530-1630
        • Pfizer Investigational Site
      • Mineola, New York, United States, 11501
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28204
        • Pfizer Investigational Site
      • Concord, North Carolina, United States, 28025
        • Pfizer Investigational Site
      • Fayetteville, North Carolina, United States, 28304
        • Pfizer Investigational Site
      • Winston-salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Pfizer Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Eugene, Oregon, United States, 97401-2676
        • Pfizer Investigational Site
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Colmar, Pennsylvania, United States, 18915
        • Pfizer Investigational Site
      • Lancaster, Pennsylvania, United States, 17604
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
      • Sewickley, Pennsylvania, United States, 15143
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29201
        • Pfizer Investigational Site
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
      • Myrtle Beach, South Carolina, United States, 29572
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920-1522
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78414
        • Pfizer Investigational Site
      • Corsicana, Texas, United States, 75110
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Pfizer Investigational Site
      • Sandy, Utah, United States, 84070
        • Pfizer Investigational Site
      • Sandy, Utah, United States, 84094
        • Pfizer Investigational Site
      • West Jordan, Utah, United States, 84088
        • Pfizer Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinically significant stress urinary incontinence

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI.

Secondary Outcome Measures

Outcome Measure
To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

April 7, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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