DARWIN EU® Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  - Cisapride; - Clebopride; - Itopride; - Cinitapride
• Study drug International non-proprietary name (INN) or common name:
  DOMPERIDONE

  ERYTHROMYCIN

  METOCLOPRAMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A03FA01) metoclopramide

  metoclopramide

  (A03FA02) cisapride

  cisapride

  (A03FA03) domperidone

  domperidone

  (A03FA06) clebopride

  clebopride

  (A03FA07) itopride

  itopride

  (A03FA08) cinitapride

  cinitapride

  (J01FA01) erythromycin

  erythromycin
• Medical condition to be studied:
  Diabetic gastroparesis

  Dyspepsia

  Irritable bowel syndrome

  Vomiting

  Diabetes mellitus

  Hypothyroidism

  Scleroderma

  Parkinson's disease

  Multiple sclerosis

  Gastroptosis
• Additional medical condition(s):
  Gastroparesis syndrome, Gastroesophageal reflux disease, Chronic constipation, Systemic Lupus Erythematous, Ehlers Danlos Syndrome, Acute migraine, Cerebrovascular disease

Population studied

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

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 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)
• Estimated number of subjects:
  2000000

Study design details

• Study design:
  - New drug user cohort study; - Population-level cohort study
• Main study objective:
  The main objective of the study is to determine the dose, formulation, cumulative duration and setting at time of treatment initiation of any of the prokinetic drugs of interest for patients diagnosed with gastroparesis and to determine the incidence and prevalence of use of medications with prokinetics properties in patients diagnosed with gastroparesis, in children and adults separately.
• Data analysis plan:
  Patient-level drug utilization: Large-scale patient-level characterization will be conducted at index date including patient demographics, comorbidity and medication. Cumulative duration of use of medication with prokinetic properties, dose, formulation and different types of setting will be reported. Population-level utilization of medication with prokinetic properties: Annual period prevalence of the use of medications with prokinetics properties and annual incidence rates per 100000 person years will be estimated. For all analyses a minimum cell count of 5 will be used when reporting results, with any smaller counts obscured.