Urinary Incontinence, StressPhase 2NCT00138749
An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
A Phase 2 study testing SS-RBX in people with Urinary Incontinence, Stress, run by Pfizer at 95 sites in 2 countries.
Trial summary
A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- SS-RBX
- How many people
- 402 participants
- Where
- 95 sitesin 2 countries
- Study dates
- Nov 2004to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically significant stress urinary incontinence
Who cannot join
- History or evidence of any relevant confounding urological or neurological disease
Trial locations and contacts
95 sites in 2 countries.
95 sites in 2 countries
United States89 sites
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Albuquerque, New Mexico, 87108
Pfizer Investigational Site
Alpharetta, Georgia, 30005
Pfizer Investigational Site
Anchorage, Alaska, 99508
Pfizer Investigational Site
Arlington Heights, Illinois, 60004
Pfizer Investigational Site
Atherton, California, 94027
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Bethany, Oklahoma, 73008
Pfizer Investigational Site
Burlington, North Carolina, 27215
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Charlotte, North Carolina, 28204
Pfizer Investigational Site
Chicago, Illinois, 60616
Pfizer Investigational Site
Cincinnati, Ohio, 45212
Pfizer Investigational Site
Coeur d'Alene, Idaho, 83814
Pfizer Investigational Site
Colmar, Pennsylvania, 18915
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Concord, North Carolina, 28025
Pfizer Investigational Site
Corpus Christi, Texas, 78414
Pfizer Investigational Site
Corsicana, Texas, 75110
Pfizer Investigational Site
Denver, Colorado, 80210
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Des Moines, Iowa, 50309
Pfizer Investigational Site
Edison, New Jersey, 08837
Pfizer Investigational Site
Eugene, Oregon, 97401-2676
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fayetteville, North Carolina, 28304
Pfizer Investigational Site
Garden City, New York, 11530-1630
Pfizer Investigational Site
Garden City, New York, 11530
Pfizer Investigational Site
Greenbelt, Maryland, 20770
Pfizer Investigational Site
Greenwood, Indiana, 46143
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Henderson, Nevada, 89014
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Jackson, Mississippi, 39216
Pfizer Investigational Site
Knoxville, Tennessee, 37920-1522
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Laguna Woods, California, 92653
Pfizer Investigational Site
Lancaster, Pennsylvania, 17604
Pfizer Investigational Site
Liberty, Missouri, 64068
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Louisville, Kentucky, 40291
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Melrose Park, Illinois, 60160
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
Murrieta, California, 92562
Pfizer Investigational Site
Myrtle Beach, South Carolina, 29572
Pfizer Investigational Site
New London, Connecticut, 06320
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
North Kansas City, Missouri, 64116
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Panama City, Florida, 32405
Pfizer Investigational Site
Panama City, Florida, 32407
Pfizer Investigational Site
Pembroke Pines, Florida, 33028
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Port Richey, Florida, 34668
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Poughkeepsie, New York, 12601
Pfizer Investigational Site
Providence, Rhode Island, 02904
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
Salt Lake City, Utah, 84132
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
Sandy City, Utah, 84070
Pfizer Investigational Site
Sandy City, Utah, 84094
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Sewickley, Pennsylvania, 15143
Pfizer Investigational Site
Shreveport, Louisiana, 71106
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
Tarzana, California, 91356
Pfizer Investigational Site
Temecula, California, 92591
Pfizer Investigational Site
Torrance, California, 90505
Pfizer Investigational Site
Tucson, Arizona, 85712-5803
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Virginia Beach, Virginia, 23454
Pfizer Investigational Site
Vista, California, 92084
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
West Orange, New Jersey, 07052
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Canada6 sites
Pfizer Investigational Site
Kitchener, Ontario, N2M 5N4
Pfizer Investigational Site
Montreal, Quebec, H3S 1Z1
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Surrey, British Columbia, V3V-1N1
Pfizer Investigational Site
Victoria, British Columbia, V8T5G1
About this study
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.
A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- SS-RBX
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SS-RBXDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 402 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138749
- Sponsor's protocol ID
- A6061023
- Status last verified
- Apr 2011
- First submitted
- 26 Aug 2005
- Last updated
- 7 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00138749
- Acronym / sponsor ID
- A6061023
- Conditions
- Urinary Incontinence, Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically significant stress urinary incontinence
Key exclusion criteria (1 listed)
- History or evidence of any relevant confounding urological or neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS-RBX | Drug | – |
Primary outcome
Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI.
1 secondary outcome
To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
95 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SS-RBX in people with Urinary Incontinence, Stress, run by Pfizer at 95 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011; AzTrials last refreshed its copy on 31 Oct 2026.