Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

NCT ID: NCT00190996

Last Updated: 2007-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2765 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Incontinence, Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Duloxetine Hydrochloride

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female diagnosed with stress urinary incontinence

Exclusion Criteria

* Currently taking a monoamine oxidase inhibitor
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Surrey, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19929591 (View on PubMed)

Other Identifiers

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F1J-EW-SBCC

Identifier Type: -

Identifier Source: secondary_id

8049

Identifier Type: -

Identifier Source: org_study_id

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