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NCT00190645 Clinical Trial

To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

Stress Urinary Incontinence 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 NCT00190645
Other study ID # 2688
Secondary ID F1J-MC-SBAW
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated January 24, 2007
Start date February 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 States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from Stress Urinary Incontinence.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

Successfully completed the protocol for Study F1J-MC-SBAV.

Exclusion Criteria:

Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Duloxetine

Locations
Country Name City State
Canada 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 Oakville Ontario
United States 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 Denver Colorado

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada, 

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(SUI).
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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