Status: Finalised First registered on: 25/01/2016
Last updated on: 03/04/2018
1. Study identification
EU PAS Register NumberEUPAS12194
Official titleDrug utilisation study (DUS) on flupirtine-containing medicinal products
Study title acronym
Study typeOther: Retrospective Database Analysis
Brief description of the studyRetrospective drug utilisation study using patient-level databases to characterise prescribing practices of flupirtine-containing medicinal products during routine clinical use and assess the main reasons for prescription by representative groups of prescribers before and after SmPC review
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 signed26/06/201526/06/2015
Start date of data collection30/11/201530/11/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report29/02/201611/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesHormosan100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Dombrowski
First name Silvia
Address line 1Darmstädter Landstraße 108
Address line 2 
Address line 3 
CityFrankfurt am Main 
Postcode60598 
CountryGermany
Phone number (incl. country code)49-69-66044765 
Alternative phone number 
Fax number (incl. country code) 
Email address sdombrowski@de.imshealth.com
Public Enquiries
Title Professor 
Last name Kostev 
First name Karel 
Address line 1Darmstädter Landstraße 108 
Address line 2 
Address line 3 
CityFrankfurt am Main 
Postcode60598 
CountryGermany 
Phone number (incl. country code)49-69-66044878 
Alternative phone number 
Fax number (incl. country code) 
Email address kkostev@de.imshealth.com 
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