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

Phase 2

Completed

• Conditions: Urinary Incontinence, Stress

• Registration Number: NCT00138749
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-30
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 402

Inclusion Criteria

• Clinically significant stress urinary incontinence

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Pointe-Claire, Quebec, Canada