Status: Finalised First registered on: 28/02/2013
Last updated on: 05/06/2018
1. Study identification
EU PAS Register NumberEUPAS3590
Official titlePost-authorisation Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide
Study title acronym
Study typeObservational study
Brief description of the studyThe overall goal of this research study is to find out whether use of domperidone, a gastrointestinal medication taken for symptoms of nausea and vomiting, may increase the chance of out-of-hospital sudden cardiac death (SCD) compared with the use of two other gastrointestinal medications, the proton pump inhibitor (PPI) medications as a group and metoclopramide, and during periods of non-use of all three types of study medications. Earlier studies have found an increased risk of SCD or a combined outcome of SCD and severe ventricular arrhythmia with current use of domperidone compared with non-use. Evidence from these studies suggested that risk was increased among persons aged older than 60 years and among those receiving a dose of more than 30 mg of domperidone per day orally, but there were not enough exposed individuals for a definitive answer to these questions. The current study will contribute additional information by providing an in-depth analysis of the risk of SCD in relation to domperidone by age and dose. To improve on previous studies it is designed as a nested case control and will include metoclopramide use as a comparator medication in addition to PPI medications, and a case-cross over analysis in which each subject will serve as his/her own control. The study will be performed in the CPRD linkable to Health Episode Statistics data. An important goal of the study is to examine whether higher doses of domperidone are related to higher risk of SCD than lower doses or whether patients using domperidone for longer periods of time are at higher risk. For some patients, the information needed to calculate daily dose of domperidone or length of domperidone use may be missing in the electronic database. For these patients, the researchers plan to conduct a survey of their general practitioners to gather information about dose and duration of exposure. The results of the study will be presented in a study report and in a peer reviewed manuscript.
Was this study requested by a regulator?Yes: Belgium
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Arana
First name Alejandro
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed24/07/2012
Start date of data collection01/01/201325/01/2013
Start date of data analysis28/01/201320/02/2013
Date of interim report, if expected
Date of final study report21/12/201322/08/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesJanssen Research and Development, L.L.C.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Arana
First name Alejandro
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org
Public Enquiries
Title Dr 
Last name Arana 
First name Alejandro 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org 
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