Study identification

PURI

https://redirect.ema.europa.eu/resource/39072

EU PAS number

EUPAS33397

Study ID

39072

Official title and acronym

Ranitidine and other histamine H2-receptor antagonists – a drug utilisation study

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Netherlands
Spain
United Kingdom

Study description

Results 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.

Study status

Finalised
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

ranitidine protocol_17Januari2020_FINAL_clean

English (1.56 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable