- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00190632
To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Study Overview
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44122
- 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
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Have had symptoms of SUI for at least 3 months prior to study entry.
Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).
Ambulatory and able to use a toilet independently and without difficulty.
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Exclusion Criteria:
Subjects who participated or were discontinued from any previous studies investigating duloxetine.
Use of excluded medications within 14 days prior to study entry or at any time during the study.
Subjects who currently have or have had a history of urogenital cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI)
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Secondary Outcome Measures
Outcome Measure |
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To collect data to demonstrate the maintenance of effect of duloxetine as measured by the Patient Global Impression of Improvement (PGI-I) questionnaire.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- 2690
- F1J-MC-SBAY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Eli Lilly and CompanyBoehringer IngelheimCompleted
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