A multicentre, European, observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a bowel cleansing preparation (DUS (Drug Utilisation Study))

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicentre, European, observational

Study drug and medical condition

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

  MAGNESIUM SULFATE HEPTAHYDRATE

  POTASSIUM SULPHATE

Population studied

• Short description of the study population:
  Patients who were eligible for colon preparation with BLI800 (Eziclen®/Izinova®) and provide written informed consent.; Patients were enrolled from specialised gastroenterology and hepatogastroenterology hospitals/clinics and endoscopy centres and might be inpatients or outpatients.; All patients must fulfil the following criteria:; • They are eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation And; • They sign the ICF.
• Age groups:
  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

  Renal impaired
• Estimated number of subjects:
  1285

Study design details

• Main study objective:
  The objective of this study is to assess drug utilisation in the real life setting in a representative sample of the European target population.
• Outcomes:
  Primary objective is to document the misuse of BLI800 (Eziclen®/Izinova®), defined as non-compliance in terms of insufficient liquid intake, during the postapproval period in the real life setting. Secondary objective is to describe the safety profile of BLI800 (Eziclen®/Izinova®) in routine clinical practice, overall and in case of misuse defined as non-compliance in terms of insufficient liquid intake, and identify any immediate/acute adverse events associated with the use of BLI800 (Eziclen®/Izinova®) in special populations (i.e. the elderly and patients at risk of electrolyte shifts).
• Data analysis plan:
  Sample size is based on the primary endpoint that is to say the proportion of non-compliant patients defined as having taken less than 75% of the prescribed hydration volume (2 L). The sample size for special population should represent 30% of the recruited patients. Assuming a proportion of 50%, this sample size will allow estimating the proportion with a 2- sided 95% level of confidence and a precision of +/- 5%. The total included population will represent 1285 patients.Each site will be required to offer enrolment to consecutive patients requiring bowel cleansing prior to colonoscopy and eligible for BLI800 (Eziclen®/Izinova®) in accordance with the marketing authorisation. All eligible patients at each study centre will be offered enrolment, until 65 patients are enrolled per site. However, the actual numbers will depend on the drug uptake following launch.

Documents

Study results

8-79-58800-001_abstract_redacted_3Oct18

Study publications

Regula J, Spaander M, Suchanek S, Kornowski A, Perrot V, Fischbach W. Sa1982-A …