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NCT00191087 Clinical Trial

Duloxetine in the Treatment of 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 NCT00191087
Other study ID # 2686
Secondary ID F1J-MC-SBAU
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated January 24, 2007
Start date April 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 458
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Women with predominant stress urinary incontinence.

- 7 or more incontinence episodes per week.

Exclusion Criteria:

- Use of monoamine inhibitors.

Study Design

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

Related Conditions & MeSH terms

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 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. London England

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 To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence
Secondary To collect data to demonstrate the maintenance of effect of duloxetine as measured by patient Global Impression of Improvement (PGI-I) questionnaire.
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