Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

Urinary Incontinence Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191204
• Other study ID #: 5309
• Secondary ID: F1J-MC-SBBM
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: September 2001
• Est. completion date: May 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence Stress
• Urinary Incontinence, Stress

Intervention

Drug:
• Duloxetine

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Boehringer Ingelheim

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.