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

September 12, 2005
January 24, 2007
January 2003
Not Provided
Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.
Same as current
Complete list of historical versions of study NCT00190996 on ClinicalTrials.gov Archive Site
  • Evaluate the maintenance of effect on IEF in long-term use
  • Kings Health Questionnaire
  • Patient Global Impression of Improvement Questionnaire
  • Safety effects
  • Evaluate the maintenance of effect on IEF in long-term use.
  • -Kings Health Questionnaire
  • -Patient Global Impression of Improvement Questionnaire
  • -Safety effects
Not Provided
Not Provided
 
Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence
The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence

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.

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 Hydrochloride
  • Drug: placebo
Not Provided
Cardozo L, Lange R, Voss S, Beardsworth A, Manning M, Viktrup L, Zhao YD. Short- and long-term efficacy and safety of duloxetine in women with predominant stress urinary incontinence. Curr Med Res Opin. 2010 Feb;26(2):253-61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2765
June 2006
Not Provided

Inclusion Criteria:

  • Female diagnosed with stress urinary incontinence

Exclusion Criteria:

  • Currently taking a monoamine oxidase inhibitor
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00190996
8049, F1J-EW-SBCC
Not Provided
Not Provided
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
Eli Lilly and Company
January 2007

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