Status: Finalised First registered on: 26/10/2015
Last updated on: 30/03/2018
1. Study identification
EU PAS Register NumberEUPAS11391
Official titleDrug utilisation study (DUS) on flupirtine-containing products Retrospective drug utilisation study using patient-level databases to characterise prescribing practices of flupirtine-containing drugs during routine clinical use and assess the main reasons for prescription by representative groups of prescribers
Study title acronym
Study typeObservational study
Brief description of the studyCohort study with pre-post design using a longitudinal patient level Electronic Medical Records (EMR) database and a longitudinal patient level prescription database for Germany. The DUS will be carried out in Germany because more than 90% of total prescriptions for flupirtine-containing medicinal products of MAHs in European Union Member States were issued in Germany.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Massoud
First name Toussi
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

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/09/201530/09/2015
Start date of data collection01/10/201601/10/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201611/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTEVA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Massoud
First name Toussi
Address line 15-7 place des Pyramides
Address line 2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com
Public Enquiries
Title Dr 
Last name Massoud 
First name Toussi 
Address line 15-7 place des Pyramides 
Address line 2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance 
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com 
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