Status: Finalised First registered on: 02/12/2013
Last updated on: 20/06/2017
1. Study identification
EU PAS Register NumberEUPAS5333
Official titleAnnual investigate of EMEND prescription
Study title acronym
Study typeObservational study
Brief description of the studyEMEND® (aprepitant) is an anti-emetic drug indicated for the prevention of nausea and vomiting associated with acute and delayed highly emetogenic cancer chemotherapy including cisplatin, and with moderately emetogenic chemotherapy. Annual monitoring of the conditions of use of this drug has been requested to MSD France laboratory by the Transparency Committee and the Economic Committee for Health Products. Using Onco-Analyser/IMS Health database, the objective of the study is to check EMEND® compliance in real life: profile of patients, type of cancer, chemotherapy and/or other previous treatments, daily dose, duration of treatment and associated treatments, and to make an annual follow-up of the respect of the conditions of use of EMEND® in comparison with the Therapeutic Information Sheet, over 8 years.
Was this study requested by a regulator?Yes: France
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsPELyon
Department/Research groupUnité de Pharmacoépidémiologie
Organisation/affiliationUniversité Claude Bernard Lyon 1
Website/Homepagehttp://eia.univ-lyon1.fr
Details of (Primary) lead investigator
Title Dr
Last name VAN GANSE
First name Eric
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

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/01/2005
Start date of data collection01/09/2005
Start date of data analysis
Date of interim report, if expected
Date of final study report28/02/201415/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMSD FRANCE100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name VAN GANSE
First name Eric
Address line 1Unité de Pharmacoépidémiologie
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr
Public Enquiries
Title Dr 
Last name VAN GANSE 
First name Eric 
Address line 1Unité de Pharmacoépidémiologie 
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance 
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr 
Top