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To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190645
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  Purpose

The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from Stress Urinary Incontinence.


Condition Intervention Phase
Stress Urinary Incontinence
 Drug: Duloxetine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI).

Secondary Outcome Measures:
  • To collect data to demonstrate the maintenance of effect of duloxetine as measured by Patient Global Impression of Improvement (PGI-I) questionnaire.

Estimated Enrollment: 600
Study Start Date: February 2001
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Successfully completed the protocol for Study F1J-MC-SBAV.

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Exclusion Criteria:

Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190645

Locations
United States, Colorado
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
Denver, Colorado, United States, 80220
Canada, Ontario
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
Oakville, Ontario, Canada, L6H3P1
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190645     History of Changes
Other Study ID Numbers: 2688, F1J-MC-SBAW
Study First Received: September 12, 2005
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013