Study identification

PURI

https://redirect.ema.europa.eu/resource/42946

EU PAS number

EUPAS38902

Study ID

42946

Official title and acronym

Comparative risk of the incident cancer between histamine-2 receptor antagonists (Risk of cancer between H2RAs)

DARWIN EU® study

No

Study countries

France
Germany
Korea, Republic of
Spain
United Kingdom
United States

Study description

Dietary N-nitrosodimethylamine (NDMA) has been shown to be carcinogenic in animals, however, evidence from population-based studies is inconlusive. The U.S. Food and Drug Administration has issued a statement on ranitidine because they may contain unacceptable levels of NDMA in 2019. To date, there have been several studies regarding association between NDMA exposure and risk of cancer, however, real-world evidence of cancer risk in relation with ranitidine is scarce. We aim to evaluate the comparative risk of incident cancer in patients exposed to various H2 receptor antagonists (H2RAs). We will conduct systematic, multinational study to estimate the relative risk of primary outcome (overall cancer except non-melanoma skin cancer) and secondary outcomes (overall cancer, overall cancer except thyroid cancer, 16 types of cancer, and cancer mortality) in ranitidine cohort. We will compare the target cohort with the comparator cohort for the hazards of outcome during the time-at-risk by applying a Cox proportional hazards model after propensity score adjustment.

Study status

Planned
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
Ajou University
First published:
01/02/2024
Institution
IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
NHIS South Korea, Hanyang University South Korea, Ajou University South Korea, Kangdong Sacred Heart Hospital South Korea, Columbia University US, Stanford University US, IQVIA US

Contact details

Seng Chan You

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Data collection

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Ministry of Health & Welfare, Republic of Korea. grant number: HI19C0143
Study protocol
Initial protocol

H2RACancerRisk_Protocol_V0.5

English (679.44 KB - PDF)View document
Updated protocol

H2RACancerRisk_Protocol_V0.5.1

English (691.94 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Non-EU RMP only