Study identification

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 institutions and networks

Institutions

Multiple centres: 100 centres are involved in the study

Contact details

Intissar Bourahla

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Marketing Authorization Holder
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)