Drug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic use in France and Italy: an electronic medical records databases study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33991
• EU PAS number:
  EUPAS11081
• Study ID:
  33991
• Official title and acronym:
  Drug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic use in France and Italy: an electronic medical records databases study
• DARWIN EU® study:
  No
• Study countries:
  France

  Italy
• Study description:
  The aim of this drug utilization study is to characteriseprescribing practices of TCC-containing medicinal productsduring typical clinical use in representative groups ofprescribers and assess main reasons for prescription.The study objectives are:• To describe the demographic and clinicalcharacteristics of the treated patients (i.e. age andgender, co-medications, pregnancy, contraceptive use,lactation)• To describe for which indication TCC is prescribed inroutine clinical practice (overall and by age/gender)• To describe the average duration of treatment episodesand the daily doses prescribed according to the routeof administration• To compare patients characteristics pre- and postimplementationof RMMs
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 02/04/2015

Actual: 02/04/2015

Study start date

Planned: 01/09/2015

Actual: 30/06/2017

Data analysis start date

Planned: 04/09/2017

Date of interim report, if expected

Planned: 31/12/2017

Date of final study report

Planned: 31/12/2019

Actual: 26/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Marketing Authorization Holder

Study protocol

Initial protocol

Thiocolchicoside-epi-pass-dus-study-report-final -26NOV19

Updated protocol

Thiocolchicoside_DUS protocol 5.0_02 MAR 2017_bis_clean_FINAL_with annexes

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)