Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190996
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
  Purpose

The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.


Condition Intervention Phase
Urinary Incontinence, Stress
Drug: Duloxetine Hydrochloride
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.

Secondary Outcome Measures:
  • Evaluate the maintenance of effect on IEF in long-term use
  • Kings Health Questionnaire
  • Patient Global Impression of Improvement Questionnaire
  • Safety effects

Estimated Enrollment: 2765
Study Start Date: January 2003
Estimated Study Completion Date: June 2006
  Eligibility

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

Inclusion Criteria:

  • Female diagnosed with stress urinary incontinence

Exclusion Criteria:

  • Currently taking a monoamine oxidase inhibitor
  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: NCT00190996

Locations
United Kingdom
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.
Surrey, United Kingdom, KT24 6QT
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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00190996     History of Changes
Other Study ID Numbers: 8049, F1J-EW-SBCC
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 July 24, 2014