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

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 institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 23/03/2006

Study start date

Actual: 30/06/2006

Data analysis start date

Actual: 01/03/2015

Date of final study report

Actual: 23/11/2015

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

Updated protocol

0663-162 Protocol Amendment_final-redaction

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)

Other study registration identification numbers and links

Study number: MK-0663-162NCT number: NCT01685424