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

This study has been completed.

First Received: August 26, 2005 Last Updated: October 5, 2006 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00138749

Purpose

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

Condition	Intervention	Phase
Urinary Incontinence, Stress	Drug: SS-RBX	Phase II

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	402
Study Start Date:	November 2004
Estimated Study Completion Date:	August 2006

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

History or evidence of any relevant confounding urological or neurological disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138749

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Study ID Numbers:	A6061023
Study First Received:	August 26, 2005
Last Updated:	October 5, 2006
ClinicalTrials.gov Identifier:	NCT00138749 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases
Urination Disorders

Stress
Urinary Incontinence
Reboxetine

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Pathologic Processes
Urinary Incontinence, Stress

Urologic Diseases
Urination Disorders
Stress
Urinary Incontinence

ClinicalTrials.gov processed this record on May 07, 2009