*BI-1208.22

Study Sponsor: Boehringer Ingelheim

Study Title

A double-blind, stratified, randomised, parallel, placebo-controlled, multi-centre study to assess the efficacy and safety of duloxetine (20 mg bid for 2 weeks escalating to 40 mg bid) for up to 12 weeks, compared to placebo, in community-dwelling elderly women >= 65 years of age with symptoms of stress urinary incontinence or stress-predominant mixed urinary incontinence

Medicine or Vaccine (generic name)

duloxetine hydrochloride

Sponsor Identification Number

1208.22

Trial Registry Identification Number(#'s)

NCT00244296

Medical Condition

Urinary Incontinence, Stress

Phase

Phase 4

Link to study details on the BI Clinical Study Register

http://trials.boehringer-ingelheim.com/trial_results/clinical_trials_overview.html

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT00244296?term=NCT00244296&rank=1&submit_fld_opt=

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report

Additional information about the data and documents available for this study

The study was sponsored by Boehringer Ingelheim; the license holder is Lilly.

Date Added to this Site

January 2015