Status: Finalised First registered on: 04/11/2016
Last updated on: 25/01/2018
1. Study identification
EU PAS Register NumberEUPAS16062
Official titleA Drug Utilisation Study of Domperidone in Europe Using Databases
Study title acronym
Study typeObservational study
Brief description of the studyThe 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 indications Secondary 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Ms
Last name Susan
First name Oliveria
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
International study

Belgium
France
Germany
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/10/2016
Start date of data collection09/02/201727/02/2017
Start date of data analysis16/03/201707/06/2017
Date of interim report, if expected
Date of final study report21/08/201715/12/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesDomperidone Collaboration Study Group100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Fife
First name Daniel
Address line 1Janssen R&D US
Address line 21125 Trenton Harbourton Road 
Address line 3 
CityTitusville 
Postcode08560 NJ 
CountryUnited States
Phone number (incl. country code)16097303419 
Alternative phone number 
Fax number (incl. country code) 
Email address dfife@its.jnj.com
Public Enquiries
Title Dr 
Last name Theuwissen 
First name Maarten 
Address line 1Janssen R&D BE 
Address line 2Turnhoutseweg, 30 
Address line 3 
CityBeerse 
Postcode2340 
CountryBelgium 
Phone number (incl. country code)3214641516 
Alternative phone number 
Fax number (incl. country code) 
Email address MTHEUWI1@its.jnj.com 
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