Efficacy and Safety of Duloxetine

Urinary Stress Incontinence Clinical Trial

Official title:

Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190619
• Other study ID #: 2624
• Secondary ID: F1J-MC-SBAM
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: May 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 purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female out patients.

• Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

Exclusion Criteria:

• Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study.

• Suffer from severe constipation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Drug:
• Duloxetine

• Placebo

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) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hrs, EST) or speak with your personal physician.	London

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	Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence
Secondary	Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint.
Secondary	Compare the efficacy of duloxetine with that of placebo measured by: Patient Global Impression Improvement questionnaire, Symptoms Frequency & Bothersomeness Questionnaire, and percent change in weekly pad usage
Secondary	Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores
Secondary	Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4)
Secondary	Compare the safety of duloxetine with that of placebo in the treatment of genuine stress incontinence based on vital signs, laboratory values, electrocardiogram findings, and the occurrence of treatment-emergent adverse events