A Post-Authorisation Safety Study (PASS) to Assess the Effectiveness of the Risk Minimisation Measures of Domperidone – Physician Survey

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19694
• EU PAS number:
  EUPAS16095
• Study ID:
  19694
• Official title and acronym:
  A Post-Authorisation Safety Study (PASS) to Assess the Effectiveness of the Risk Minimisation Measures of Domperidone – Physician Survey
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Spain

  United Kingdom
• Study description:
  Multi-national, non-interventional cross-sectional study to characterise prescriber's knowledge, understanding and extent of awareness regarding the new safety information for domperidone following the change in SmPC and the distribution of DHPC.Data will be collected through a physician survey to be administered in a group of prescribers, across 5 EU countries with varying prescription volumes: Belgium, France, Germany, Spain and United Kingdom.
• Study status:
  Finalised

Research institutions and networks

Institutions

Adelphi Real World

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 31/10/2016

Study start date

Planned: 04/01/2017

Actual: 19/01/2017

Data analysis start date

Planned: 01/04/2017

Actual: 03/04/2017

Date of final study report

Planned: 30/06/2017

Actual: 27/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Domperidone DUS Collaboration Group

Study protocol

Initial protocol

PASS Study_DUS_Physician Survey_Domperidone_JNJ-17296812-AAA_0005_EDMS-ERI-90221144_8.0

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)