Status: Ongoing First registered on: 31/01/2020
Last updated on: 03/02/2020
1. Study identification
EU PAS Register NumberEUPAS33397
Official titleRANITIDINE AND OTHER HISTAMINE-H2-RECEPTOR ANTAGONISTS – A DRUG UTILISATION STUDY
Study title acronym
Study typeObservational study
Brief description of the studyResults of a preliminary laboratory analysis have shown the presence of N-Nitrosodimethylamine (NDMA), a human carcinogen, in ranitidine. At the request of the European Commission, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is evaluating all available data to assess whether patients using ranitidine are at any risk from NDMA and whether regulatory action is warranted at EU level to protect patients and public health. Data about prescribing and use patterns of ranitidine-containing medicines in EU Member States will inform on the population at risk of exposure to NDMA (or other nitrosamines) through use of ranitidine. It will also provide information on usage patterns for different substances of the class informing on usage of substances alternative to ranitidine. By means of a retrospective cohort study we aim to: i) study the prevalence and incidence of exposure to H2-receptor antagonists as a class and by individual ingredient, ii) explore the characteristics of H2-receptor antagonist use in terms of observation time, cumulative duration, cumulative dose and cumulative annual dose for the class as a whole and by individual ingredient with regard to age, sex, formulation, daily dose iii) explore the indication of use of H2-receptor antagonist by class level, individual ingredient and by formulation, iv) explore the proportion of patients treated with H2-receptor antagonists suffering from renal impairment. For this study, we will include Electronic Healthcare Record data from six primary care databases throughout Europe: IPCI (the Netherlands), SIDIAP (Spain), IMRD (UK), LPD (Belgium), DA Germany and DA France. All these databases have their data mapped to the OMOP Common Data Model.
Was this study requested by a regulator?Yes: EMA
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 belongsHealth Data Sciences
Department/Research groupDepartment of Medical Informatics - Health Data Science
Organisation/affiliationErasmusMC
Website/Homepagehttps://www.healthdatascience.nl/contact
Details of (Primary) lead investigator
Title Dr
Last name Verhamme
First name Katia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

IDIAPJGol
IQVIA
Countries in which this study is being conducted
International study

Belgium
France
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed25/11/201925/11/2019
Start date of data collection20/01/202020/01/2020
Start date of data analysis15/02/2020
Date of interim report, if expected13/03/2020
Date of final study report27/03/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verhamme
First name Katia
Address line 1Dr. Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands
Phone number (incl. country code)31107044152 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl
Public Enquiries
Title Dr 
Last name Verhamme 
First name Katia 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands 
Phone number (incl. country code)31107044152 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl 
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