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Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00191204
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Sponsor:
Collaborator:
Information provided by:

September 12, 2005
September 19, 2005
January 26, 2007
September 2001
Not Provided
The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.
Same as current
Complete list of historical versions of study NCT00191204 on ClinicalTrials.gov Archive Site
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.
The secondary objective of this study is to collect data to demostrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire.
Not Provided
Not Provided
 
Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Incontinence Stress
Drug: Duloxetine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
363
May 2006
Not Provided

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00191204
5309
F1J-MC-SBBM
Not Provided
Not Provided
Not Provided
Not Provided
Eli Lilly and Company
Boehringer Ingelheim
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
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP