Back to resultsTo Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: Have had symptoms of SUI for at least 3 months prior to study entry. Have urine leakage most often associated with activity (such as coughing, sneezing, exercise). Ambulatory and able to use a toilet independently and without difficulty. - Exclusion Criteria: Subjects who participated or were discontinued from any previous studies investigating duloxetine. Use of excluded medications within 14 days prior to study entry or at any time during the study. Subjects who currently have or have had a history of urogenital cancer.
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
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI)
Secondary Outcome Measures
To collect data to demonstrate the maintenance of effect of duloxetine as measured by the Patient Global Impression of Improvement (PGI-I) questionnaire.
Full Information
NCT ID
NCT00190632
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
NCT00190632
Brief Title
To Evaluate the Safety in Patients Taking Duloxetine 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
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Primary Outcome Measure Information:
Title
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI)
Secondary Outcome Measure Information:
Title
To collect data to demonstrate the maintenance of effect of duloxetine as measured by the Patient Global Impression of Improvement (PGI-I) questionnaire.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have had symptoms of SUI for at least 3 months prior to study entry.
Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).
Ambulatory and able to use a toilet independently and without difficulty.
-
Exclusion Criteria:
Subjects who participated or were discontinued from any previous studies investigating duloxetine.
Use of excluded medications within 14 days prior to study entry or at any time during the study.
Subjects who currently have or have had a history of urogenital cancer.
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 9 AM - 5 PM 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
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence
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