Study identification

PURI

https://redirect.ema.europa.eu/resource/19307

EU PAS number

EUPAS17526

Study ID

19307

Official title and acronym

Etoricoxib Prescribing Patterns and Adverse Events of Interest during Etoricoxib Treatment in UK Primary Care (MK-0663-162)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This postmarketing study was conducted to describe prescribing patterns for etoricoxib(ARCOXIA)® in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).

Study status

Finalised
Research institution and networks

Institutions

Merck & Co.
First published:
01/02/2024
Institution

Contact details

Dena Rosen Ramey, BA

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.
Study protocol
Initial protocol

0663-162 Protocol_final-redaction

English (1.96 MB - PDF)View document
Updated protocol

0663-162 Protocol Amendment_final-redaction

English (1.01 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)