NCT00138749

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

Geographic Reach
2 countries

95 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

August 26, 2005

Last Update Submit

April 6, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

SS-RBXDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically significant stress urinary incontinence

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (95)

Pfizer Investigational Site

Anchorage, Alaska, 99508, United States

Location

Pfizer Investigational Site

Sun City, Arizona, 85351, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712-5803, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Atherton, California, 94027, United States

Location

Pfizer Investigational Site

Carmichael, California, 95608, United States

Location

Pfizer Investigational Site

Laguna Woods, California, 92653, United States

Location

Pfizer Investigational Site

Murrieta, California, 92562, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660, United States

Location

Pfizer Investigational Site

Sacramento, California, 95825, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

Tarzana, California, 91356, United States

Location

Pfizer Investigational Site

Temecula, California, 92591, United States

Location

Pfizer Investigational Site

Torrance, California, 90505, United States

Location

Pfizer Investigational Site

Vista, California, 92084, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80012, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80210, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80220, United States

Location

Pfizer Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

Pfizer Investigational Site

New London, Connecticut, 06320, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

Aventura, Florida, 33180, United States

Location

Pfizer Investigational Site

New Port Richey, Florida, 34652, United States

Location

Pfizer Investigational Site

Panama City, Florida, 32405, United States

Location

Pfizer Investigational Site

Panama City, Florida, 32407, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33028, United States

Location

Pfizer Investigational Site

Port Richey, Florida, 34668, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Pfizer Investigational Site

Alpharetta, Georgia, 30005, United States

Location

Pfizer Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

Pfizer Investigational Site

Arlington Heights, Illinois, 60004, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60616, United States

Location

Pfizer Investigational Site

Melrose Park, Illinois, 60160, United States

Location

Pfizer Investigational Site

Greenwood, Indiana, 46143, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Des Moines, Iowa, 50309, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40291, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71106, United States

Location

Pfizer Investigational Site

Greenbelt, Maryland, 20770, United States

Location

Pfizer Investigational Site

Watertown, Massachusetts, 02472, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, 39202, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, 39216, United States

Location

Pfizer Investigational Site

Liberty, Missouri, 64068, United States

Location

Pfizer Investigational Site

North Kansas City, Missouri, 64116, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68114, United States

Location

Pfizer Investigational Site

Henderson, Nevada, 89014, United States

Location

Pfizer Investigational Site

Edison, New Jersey, 08837, United States

Location

Pfizer Investigational Site

West Orange, New Jersey, 07052, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

Pfizer Investigational Site

Albany, New York, 12208, United States

Location

Pfizer Investigational Site

Garden City, New York, 11530-1630, United States

Location

Pfizer Investigational Site

Garden City, New York, 11530, United States

Location

Pfizer Investigational Site

Mineola, New York, 11501, United States

Location

Pfizer Investigational Site

Poughkeepsie, New York, 12601, United States

Location

Pfizer Investigational Site

Burlington, North Carolina, 27215, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28204, United States

Location

Pfizer Investigational Site

Concord, North Carolina, 28025, United States

Location

Pfizer Investigational Site

Fayetteville, North Carolina, 28304, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45212, United States

Location

Pfizer Investigational Site

Bethany, Oklahoma, 73008, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401-2676, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

Medford, Oregon, 97504, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Pfizer Investigational Site

Colmar, Pennsylvania, 18915, United States

Location

Pfizer Investigational Site

Lancaster, Pennsylvania, 17604, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Pfizer Investigational Site

Sellersville, Pennsylvania, 18960, United States

Location

Pfizer Investigational Site

Sewickley, Pennsylvania, 15143, United States

Location

Pfizer Investigational Site

Providence, Rhode Island, 02904, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29425, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29201, United States

Location

Pfizer Investigational Site

Greer, South Carolina, 29651, United States

Location

Pfizer Investigational Site

Myrtle Beach, South Carolina, 29572, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37920-1522, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37920, United States

Location

Pfizer Investigational Site

Corpus Christi, Texas, 78414, United States

Location

Pfizer Investigational Site

Corsicana, Texas, 75110, United States

Location

Pfizer Investigational Site

Houston, Texas, 77024, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84132, United States

Location

Pfizer Investigational Site

Sandy City, Utah, 84070, United States

Location

Pfizer Investigational Site

Sandy City, Utah, 84094, United States

Location

Pfizer Investigational Site

West Jordan, Utah, 84088, United States

Location

Pfizer Investigational Site

Virginia Beach, Virginia, 23454, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98104, United States

Location

Pfizer Investigational Site

Surrey, British Columbia, V3V-1N1, Canada

Location

Pfizer Investigational Site

Victoria, British Columbia, V8T5G1, Canada

Location

Pfizer Investigational Site

Kitchener, Ontario, N2M 5N4, Canada

Location

Pfizer Investigational Site

Oakville, Ontario, L6H 3P1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3S 1Z1, Canada

Location

Pfizer Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Related Links

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

November 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations