Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

This study has been completed.

Sponsor:

Collaborator:

Boehringer Ingelheim Pharmaceuticals

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00190827

First received: September 12, 2005

Last updated: January 24, 2007

Last verified: January 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 24, 2007

Start Date ^ICMJE

September 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase.
Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00190827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of overall patient safety.
Reduction of IEFs using standardized instruments.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

Official Title ^ICMJE

The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence

Brief Summary

The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Urinary Incontinence, Stress

Intervention ^ICMJE

Drug: duloxetine
Drug: placebo

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

May 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

female outpatients > or = 18 years of age
experience episodes of stress urinary incontinence
must have an educational level and degree of understanding English
are free of urinary tract infections
can use the toilet independently

Exclusion Criteria:

any in or outpatient surgery in the last six months
suffer from severe constipation
extension of any internal organs beyond vaginal opening
currently breastfeeding
any nervous diseases affecting normal urinary function

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain

Administrative Information

NCT Number ^ICMJE

NCT00190827

Other Study ID Numbers ^ICMJE

6195, F1J-MC-SBBR

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Investigators ^ICMJE

Study Director:

Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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