Efficacy and Safety of Duloxetine
Phase 3
Completed
- Conditions
- Urinary Stress Incontinence
- Registration Number
- NCT00190619
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence
- Secondary Outcome Measures
Name Time Method Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint. 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 Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4) 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
Trial Locations
- Locations (1)
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, United Kingdom