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. Identifier: NCT00138749
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : April 7, 2011
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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)
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
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00138749

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc 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
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders