Back to resultsEvaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence
Primary Purpose
Urinary Incontinence, Stress
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress
Eligibility Criteria
Inclusion Criteria: Female diagnosed with stress urinary incontinence Exclusion Criteria: Currently taking a monoamine oxidase inhibitor
Sites / Locations
- 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.
Outcomes
Primary Outcome Measures
Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.
Secondary Outcome Measures
Evaluate the maintenance of effect on IEF in long-term use
Kings Health Questionnaire
Patient Global Impression of Improvement Questionnaire
Safety effects
Full Information
NCT ID
NCT00190996
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00190996
Brief Title
Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence
Official Title
The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2765 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.
Secondary Outcome Measure Information:
Title
Evaluate the maintenance of effect on IEF in long-term use
Title
Kings Health Questionnaire
Title
Patient Global Impression of Improvement Questionnaire
Title
Safety effects
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female diagnosed with stress urinary incontinence
Exclusion Criteria:
Currently taking a monoamine oxidase inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Surrey
ZIP/Postal Code
KT24 6QT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19929591
Citation
Cardozo L, Lange R, Voss S, Beardsworth A, Manning M, Viktrup L, Zhao YD. Short- and long-term efficacy and safety of duloxetine in women with predominant stress urinary incontinence. Curr Med Res Opin. 2010 Feb;26(2):253-61. doi: 10.1185/03007990903438295.
Results Reference
derived
Learn more about this trial
Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence
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