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To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190632
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
  Purpose
This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with 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:


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 the Patient Global Impression of Improvement (PGI-I) questionnaire.

Estimated Enrollment: 600
Study Start Date: March 2001
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190632

Locations
United States, Ohio
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
Cleveland, Ohio, United States, 44122
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
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

ClinicalTrials.gov Identifier: NCT00190632     History of Changes
Other Study ID Numbers: 2690  F1J-MC-SBAY 
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
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents

ClinicalTrials.gov processed this record on December 07, 2016