Status: Finalised First registered on: 03/12/2015
Last updated on: 09/03/2018
1. Study identification
EU PAS Register NumberEUPAS11765
Official titleEvaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Thiocolchicoside containing Medicinal Products for Systemic Use in France, Greece, Italy and Portugal
Study title acronym
Study typeObservational study
Brief description of the studyThiocolchicoside (TCC) is a semi-synthetic sulfurated colchicoside derivative with a muscle relaxant pharmacological activity, used in the management of non-specific low back pain. TCC is indicated as adjuvant treatment of painful muscular contractures in acute spinal pathology, in adults and adolescents from 16 years onwards. The benefits of TCC containing medicinal products are recognised in clinical practice, and they are widely used by prescribers in the concerned Member States (see Annex 3). An Article 31 referral on thiocolchicoside-containing medicinal products for systemic use was initiated in February 2013. The CHMP has concerns with regard to the potential genotoxicity of thiocolchicoside-containing medicinal products for systemic use. Within the context of minimization measures as per European Commission decision dated 17 January 2014, including a Dear Healthcare Professional Communication, changes to the SmPC, Labelling and Package Leaflet. As per EMA request the present survey will be conducted in complement to a Joint Drug Utilization Study.
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
International study

France
Greece
Italy
Portugal
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/11/201520/11/2015
Start date of data collection01/04/201601/02/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report31/01/201701/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAcarpia services farmaceuticos Lda, Alter laboratoire, Angelini, Angenerico SpA, Arrow Generiques, Biogaran, Cristers, Daiichi Sankyo, Doc Generici, Dompe Farmaceutici SpA, EG labo, EG SpA, Epifarma Srl, Farmaceutici Caber SpA, Generis Farmaceutica,100
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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