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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31317
• EU PAS number:
  EUPAS9361
• Study ID:
  31317
• Official title and acronym:
  A multicentre, European, observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a bowel cleansing preparation (DUS (Drug Utilisation Study))
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Germany

  Netherlands

  Poland
• Study description:
  The postapproval commitments for BLI800 (Eziclen®/Izinova®) in EU included a request that Ipsen Pharma conducts a DUS to assess drug utilisation in the real life setting in a representative sample of the European target population. The objectives of this DUS are:• Primary objective: 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: 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).
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 16 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 02/12/2013

Actual: 12/11/2014

Study start date

Planned: 01/10/2015

Actual: 12/10/2015

Data analysis start date

Planned: 03/10/2016

Actual: 04/07/2016

Date of interim report, if expected

Planned: 30/12/2016

Actual: 22/12/2016

Date of final study report

Planned: 31/12/2017

Actual: 02/02/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

IPSEN PHARMA SAS

Study protocol

Initial protocol

8-79-58800-001_protocol_redacted_3Oct18

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)