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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  THIOCOLCHICOSIDE

Population studied

• Short description of the study population:
  All patients with at least one prescription of Thiocolchicoside (TCC)-containing medicinal products for systemic use in the selected databases during the study periods, i.e. before (baseline: year 2013) or after the implementation of the minimization measures
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  To characterise prescribing practices of TCC-containing medicinal products during typical clinical use and assess main reasons for prescription.To describe the demographic and clinical characteristics of the treated patientsTo describe the average duration of treatment episodes and the daily doses prescribed according to the route of administration
• Data analysis plan:
  A descriptive analysis of TCC utilization will be performed:Indication,Dosage,Duration, Therapeutic regimen: mono-therapies or adjuvant therapies (use of TCC along with other pre- specified co-medications).Description of drug utilization by age and gender Description of prevalent and incidence