A Drug Utilisation Study of Domperidone in Europe Using Databases

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22405
• EU PAS number:
  EUPAS16062
• Study ID:
  22405
• Official title and acronym:
  A Drug Utilisation Study of Domperidone in Europe Using Databases
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Spain

  United Kingdom
• Study description:
  The objective of the study is to investigate the effectiveness of risk minimisation measures and describe prescribing patterns of domperidone, including those pertaining to the off-label use of domperidone, in routine clinical practice in 5 European Union countries.Primary Objectives: To describe the prescribing patterns before and after the changes to the domperidone label and estimate and compare the overall proportion of domperidone prescriptions before and after implementation of the risk minimisation measures regarding the following measures:- Composite endpoint consisting of the following components: - Maximum daily dose, - Duration of use (>7 days) - Concomitant medications that prolong the QT-interval or are potent CYP3A4 inhibitors, - Prescribing to patients with contraindicated conditions, e.g., moderate or severe liver disease, underlying cardiac diseases, and - Prescribing for off-label indicationsSecondary Objectives: To estimate the overall proportion of domperidone prescriptions before and after implementation of the risk minimisation measures for domperidone for each of the components of the composite endpoint individually, the time trend of apparent indication, and days supplied (≤7 days vs. >7 days), and the age and sex of the people receiving prescriptions.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Actual: 20/10/2016

Study start date

Planned: 09/02/2017

Actual: 27/02/2017

Data analysis start date

Planned: 16/03/2017

Actual: 07/06/2017

Date of final study report

Planned: 21/08/2017

Actual: 15/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Domperidone Collaboration Study Group

Study protocol

Initial protocol

DOMP - PASS Database Survey Protocol V2FINAL20JULY2016

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)