A drug utilisation study of Rifaxamin-α 550mg

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Name of medicine, other:
  Targaxan

Population studied

• Short description of the study population:
  Patients in the UK who were prescribed Rifaxamin 550mg.
• 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:
  400

Study design details

• Main study objective:
  To determine the characteristics of patients in the UK prescribed Rifaxamin 550mg and to gain understanding of the risk associated with use of Rifaxamin 550mg and paediatric use, off-label use and drug-drug interactions
• Data analysis plan:
  The drug utilisation study will characterise the dosing, formulation, the indications and the patient demographics associated with rifaxamin 550mg tablets across the UK following launch in January 2013. Tables of descriptive data (including counts, mean, median, standard deviation and interquartile range) on each patient cohort will be presented.