Efficacy and Safety of Duloxetine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190619
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Brief Summary:
The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Drug: Duloxetine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence
Study Start Date : May 2001
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence

Secondary Outcome Measures :
  1. Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint.
  2. Compare the efficacy of duloxetine with that of placebo measured by: Patient Global Impression Improvement questionnaire, Symptoms Frequency & Bothersomeness Questionnaire, and percent change in weekly pad usage
  3. Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores
  4. Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4)
  5. Compare the safety of duloxetine with that of placebo in the treatment of genuine stress incontinence based on vital signs, laboratory values, electrocardiogram findings, and the occurrence of treatment-emergent adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female out patients.
  • Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

Exclusion Criteria:

  • Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study.
  • Suffer from severe constipation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190619

United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hrs, EST) or speak with your personal physician.
London, United Kingdom
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
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 Identifier: NCT00190619     History of Changes
Other Study ID Numbers: 2624
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents