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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00138749
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : April 7, 2011
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Drug: SS-RBX Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : November 2004
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically significant stress urinary incontinence

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138749


  Show 95 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00138749     History of Changes
Other Study ID Numbers: A6061023
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders