Observational pharmaco-epidemiological study on the use of Izalgi®

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Study drug and medical condition

• Name of medicine, other:
  IZALGI
• Medical condition to be studied:
  Pain management

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  1300

Study design details

• Main study objective:
  To describe the conditions of use of Izalgi® over a 6-month period in real treatment situations
• Outcomes:
  to describe the conditions of use of Izalgi® over a 6-month period in real treatment situations, To estimate and describe, in real 6-month treatment situations:• The characteristics of patients treated with Izalgi®,• The misuse of the product on the following points:- Indication of Izalgi®,- Contraindications of Izalgi®,- Posology,- Duration of treatment,• A drug abuse or dependence,• The efficacy of the product,• Overall tolerance,• Adverse Drug Reactions.
• Data analysis plan:
  Description of the population of participating physiciansThe data collected on the physicians having participated in the study are described for the entire sample. The representativeness of the participating physicians from all GPs prescribing Izalgi® will be checked, provided that the number of response forms sent by non participants is sufficient. A comparison between the physicians and the prescribers of Izalgi® (in terms of age, sex, and region of practice) is also planned, by means of an analysis of the EGB base (cf. chapter 12.2 Representativeness of patients included).Cf protocol.