To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms
NCT ID: NCT00244296
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
PHASE4
Total Enrollment
276 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-10-31
Study Completion Date
2007-01-31
Brief Summary
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The purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms.
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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 outpatient greater than or equal to 65 years of age
* have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months
* have at least 7 incontinence episodes per week. For patients with MUI, at least 50% of the IEF must be due to stress.
* is ambulatory and able to use a toilet independently and without difficulty
* have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months
* have at least 7 incontinence episodes per week. For patients with MUI, at least 50% of the IEF must be due to stress.
* is ambulatory and able to use a toilet independently and without difficulty
Exclusion Criteria
* at Visit 1 have a positive urine culture or a history of four or more urinary tract infections (UTIs) in the preceding year
* have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry
* began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study.
* have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or Parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract.
* intake of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomisation or at any time during the study
* have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry
* began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study.
* have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or Parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract.
* intake of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomisation or at any time during the study
Minimum Eligible Age
65 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.
Champcueil, , France
Site Status
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Limoges, , France
Site Status
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Nice, , France
Site Status
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Nîmes, , France
Site Status
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Paris, , France
Site Status
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Alzey, , Germany
Site Status
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Bad Ems, , Germany
Site Status
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Düsseldorf, , Germany
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Karlsruhe, , Germany
Site Status
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Koblenz, , Germany
Site Status
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Leipzig, , Germany
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Mühlacker, , Germany
Site Status
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Rheinstetten/Baden, , Germany
Site Status
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Vellmar, , Germany
Site Status
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Wiesloch, , Germany
Site Status
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Amsterdam, , Netherlands
Site Status
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Apeldoorn, , Netherlands
Site Status
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Nieuwegein, , Netherlands
Site Status
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Tilburg, , Netherlands
Site Status
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Zeist, , Netherlands
Site Status
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Johannesburg, , South Africa
Site Status
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Barcelona, , Spain
Site Status
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Castellon, , Spain
Site Status
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Santa Cruz de Tenerife, , Spain
Site Status
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Vigo, , Spain
Site Status
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Lund, , Sweden
Site Status
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Stockholm, , Sweden
Site Status
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Uppsala, , Sweden
Site Status
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Basel, , Switzerland
Site Status
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Riehen, , Switzerland
Site Status
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Zurich, , Switzerland
Site Status
Countries
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France
Germany
Netherlands
South Africa
Spain
Sweden
Switzerland
Other Identifiers
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F1J-MC-SBCM
Identifier Type: -
Identifier Source: secondary_id
8672
Identifier Type: -
Identifier Source: org_study_id
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