Back to resultsOpen Label Phase III Duloxetine Study for Stress Urinary Incontinence
Primary Purpose
Urinary Incontinence Stress
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence Stress
Eligibility Criteria
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)
Sites / Locations
- 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.
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00191204
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00191204
Brief Title
Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
Official Title
Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
363 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 Mon - Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Peterborough
ZIP/Postal Code
PE3 6JG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
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