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Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190814
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes

September 12, 2005
January 24, 2007
September 2003
Not Provided
The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary incontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint.
The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary intcontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint.
Complete list of historical versions of study NCT00190814 on ClinicalTrials.gov Archive Site
  • Additional assessments of incontinence episode frequency using various standardized instruments will be performed.
  • To monitor the safety of duloxetine based on clinical laboratory values and the occurrence of treatment-emergent adverse events.
  • Additional assessments of incontinence episode frequency using various standardized instruments will be performed.
  • To monitor the safety of duloxetine based on clinical laboratory values and the occurrence of treatement-emergent adverse events.
Not Provided
Not Provided
 
Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.
Efficacy and Safety of Duloxetine Compared With Placebo in Women With Symptoms of Mixed Urinary Incontinence.

The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary incontinence(leakage of urine)occurrences in women due to physical stress and leakage that occurs during a strong need(urge) to urinate.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Urinary Incontinence, Stress
  • Drug: duloxetine
  • Drug: placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
May 2006
Not Provided

Inclusion Criteria:

  • female outpatients greater than or equal to 18 years of age.
  • experience episodes of urinary incontinence based on diagnostic criteria of at least 4 episodes a week with symptoms for a minimum of three months prior to start of study.
  • have an educational level and degree of understanding English.
  • are free of urinary tract infections.
  • have a discreet episodes of incontinence(i.e. dry between episodes and do not continuously leak.)

Exclusion Criteria:

  • have received treatment for incontinence within the last 5 years.
  • suffer from severe constipation.
  • currently nursing or breast feeding.
  • any nervous system disease that would affect normal urinary function.
  • any extension of internal organs beyond the vaginal opening.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT00190814
6192, F1J-MC-SBBO
Not Provided
Not Provided
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
Study Director: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP