Status: Finalised First registered on: 01/10/2014
Last updated on: 03/08/2017
1. Study identification
EU PAS Register NumberEUPAS7584
Official titleHepatic Outcomes Among Adults Taking Duloxetine in
Study title acronymF1J-MC-B037
Study typeObservational study
Brief description of the studyWe conducted a retrospective matched cohort study to evaluate the association of clinically significant hepatic injury and exposure to duloxetine, with specific definitional and methodological enhancements to focus on potential drug-related associations. The primary study objective was to estimate the absolute and relative incidence of clinically significant hepatic events (hepatic-related death, liver failure, other clinically significant liver injury, hepatic-related death and liver failure combined, all clinically significant hepatic injury categories combined) among patients with depression who initiated duloxetine relative to each of 3 propensity score-matched comparison cohorts: patients with depression who initiated venlafaxine, patients with depression who initiated SSRIs, and patients with a diagnosis of depression who did not receive treatment. Secondary objectives addressed a range of potential alternative explanations for the observed results (e.g., residual confounding).
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOptum
Department/Research groupEpidemiology
Organisation/affiliationOptum
Website/Homepagehttp://www.optum.com
Details of (Primary) lead investigator
Title Dr
Last name Li
First name Hu
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/201007/12/2012
Start date of data collection01/04/201007/12/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report01/05/201320/09/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Li
First name Hu
Address line 1Eli Lilly and Company
Address line 2Lilly Corporate Center 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States
Phone number (incl. country code)1-3176559951 
Alternative phone number 
Fax number (incl. country code) 
Email address li_hu_hl@lilly.com
Public Enquiries
Title Dr 
Last name Li 
First name Hu 
Address line 1Eli Lilly and Company 
Address line 2Lilly Corporate Center 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States 
Phone number (incl. country code)1-3176559951 
Alternative phone number 
Fax number (incl. country code) 
Email address li_hu_hl@lilly.com 
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