Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

NCT ID: NCT00191204

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

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2006-05-31

Brief Summary

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The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

Detailed Description

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Conditions

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Urinary Incontinence Stress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Duloxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female out patients
* Are ambulatory and are able to use a toilet independently and without difficulty.

Exclusion Criteria

* Use of monoamine oxidase inhibitors (MAOIs)
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 9am - 5pm 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.

Peterborough, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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F1J-MC-SBBM

Identifier Type: -

Identifier Source: secondary_id

5309

Identifier Type: -

Identifier Source: org_study_id

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