Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00191204
Collaborator
Boehringer Ingelheim (Industry)
363
1
56
6.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Study Start Date
:
Sep 1, 2001
Study Completion Date
:
May 1, 2006
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)
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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours EST), or speak with your personal physician. | Peterborough | United Kingdom | PE3 6JG |
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 9am - 5pm 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:
NCT00191204
Other Study ID Numbers:
- 5309
- F1J-MC-SBBM
First Posted:
Sep 19, 2005
Last Update Posted:
Jan 26, 2007
Last Verified:
Jan 1, 2007
Additional relevant MeSH terms: