Efficacy and Safety of Duloxetine

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00190619

Collaborator

Boehringer Ingelheim (Industry)

100

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

Condition or Disease	Intervention/Treatment	Phase
Urinary Stress Incontinence	Drug: Duloxetine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence

Study Start Date :

May 1, 2001

Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence []

Secondary Outcome Measures

Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint. []
Compare the efficacy of duloxetine with that of placebo measured by: Patient Global Impression Improvement questionnaire, Symptoms Frequency & Bothersomeness Questionnaire, and percent change in weekly pad usage []
Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores []
Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4) []
Compare the safety of duloxetine with that of placebo in the treatment of genuine stress incontinence based on vital signs, laboratory values, electrocardiogram findings, and the occurrence of treatment-emergent adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female out patients.
Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

Exclusion Criteria:

Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study.
Suffer from severe constipation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hrs, EST) or speak with your personal physician.	London		United Kingdom

Sponsors and Collaborators

Eli Lilly and Company
Boehringer Ingelheim

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00190619

Other Study ID Numbers:

2624
F1J-MC-SBAM

First Posted:

Sep 19, 2005

Last Update Posted:

Jan 26, 2007

Last Verified:

Jan 1, 2007

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Duloxetine Hydrochloride

Study Results

No Results Posted as of Jan 26, 2007