Status: Finalised First registered on: 24/09/2015
Last updated on: 05/03/2020
1. Study identification
EU PAS Register NumberEUPAS11081
Official titleDrug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic
Study title acronym
Study typeOther: Drug Utilization study
Brief description of the studyThe aim of this drug utilization study is to characterise prescribing practices of TCC-containing medicinal products during typical clinical use in representative groups of prescribers and assess main reasons for prescription. The study objectives are: • To describe the demographic and clinical characteristics of the treated patients (i.e. age and gender, co-medications, pregnancy, contraceptive use, lactation) • To describe for which indication TCC is prescribed in routine clinical practice (overall and by age/gender) • To describe the average duration of treatment episodes and the daily doses prescribed according to the route of administration • To compare patients characteristics pre- and postimplementation of RMMs
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 Mrs
Last name Bourahla
First name Intissar
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?100
Countries in which this study is being conducted
International study

France
Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/04/201502/04/2015
Start date of data collection01/09/201530/06/2017
Start date of data analysis04/09/2017
Date of interim report, if expected31/12/2017
Date of final study report31/12/201926/11/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMarketing Authorization Holder100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Bourahla
First name Intissar
Address line 1IQVIA - Tour D2
Address line 217 bis place des Reflets 
Address line 3TSA 64 567 
CityLa Défense Cedex 
Postcode92 099 
CountryFrance
Phone number (incl. country code)33173204195 
Alternative phone number 
Fax number (incl. country code) 
Email address ibourahla@fr.imshealth.com
Public Enquiries
Title Mrs 
Last name Bourahla 
First name Intissar 
Address line 1QuintilesIMS - Tour D2 
Address line 217 bis place des Reflets 
Address line 3TSA 64 567 
CityLa Défense Cedex 
Postcode 
CountryFrance 
Phone number (incl. country code)33173204195 
Alternative phone number 
Fax number (incl. country code) 
Email address ibourahla@fr.imshealth.com 
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