Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

January 24, 2007 updated by: Eli Lilly and Company

Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

363

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Peterborough, United Kingdom, PE3 6JG
        • For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female out patients
  • Are ambulatory and are able to use a toilet independently and without difficulty.

Exclusion Criteria:

  • Use of monoamine oxidase inhibitors (MAOIs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.

Secondary Outcome Measures

Outcome Measure
The secondary objective of this study is to collect data to demonstrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 26, 2007

Last Update Submitted That Met QC Criteria

January 24, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5309
  • F1J-MC-SBBM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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