Drug Utilization Study to Characterize the Prescribing Practice of Flupirtine-containing Medicinal Products during Typical Clinical Use and to Assess the Main Reason for Prescription (Flupirtine-3304)

Study type

• Study topic:
  Disease /health condition

  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:
  Other
• Non-interventional study design, other:
  Retrospective cohort analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N02BG07) flupirtine

  flupirtine
• Medical condition to be studied:
  Pain

Population studied

• Short description of the study population:
  All flupirtine-containing medicinal products prescribers in Germany.
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  84000

Study design details

• Main study objective:
  The overall research goal of this DUS is to describe and analyse the prescribing practice of all flupirtine-containing medicinal products in Germany during typical use in representative groups of prescribers and to assess the main reason for prescription.
• Data analysis plan:
  Statistical analyses will be exploratory using descriptive and inferential statistics. Categorical data will be summarized in contingency tables presenting frequencies and percentages (rates), with 95% confidence intervals of rates, where appropriate.