A non-interventional, population-based register study on the prescription of etoricoxib (Arcoxia®) to dental surgery patients in the Nordic countries (MK-0663-170)

Study identification

• EU PAS number:
  EUPAS7134
• Study ID:
  25929
• Official title and acronym:
  A non-interventional, population-based register study on the prescription of etoricoxib (Arcoxia®) to dental surgery patients in the Nordic countries (MK-0663-170)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  The objectives of this study are to:1) describe dispensed etoricoxib prescribed by dentists including the associated dental procedures, patient demographics, dosing, year, and country, 2) to described any dispensed etoricoxib prescribed by dentists that was not associated with dental procedures, 3) to describe off-label use of etoricoxib among patients aged less than 16 years and with doses >90 mg/day including the associated dental procedures, patient demographics, dosing, year, and country, 4) and to describe the duration of use of etoricoxib and the number of tablets dispensed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Epidemiology, Institute of Applied Economics and Health Research (ApHER)

Denmark

Institute of Applied Economics and Health Research Copenhagen, Denmark, National Institute of Public Health, University of Southern Denmark Copenhagen, Denmark, School of Public Health, University of Tampere Tampere, Finland, Department of Health Management and Health Economics, University of Oslo Oslo, Norway, University of Gothenburg, Centre for Health Economics Gothenburg, Sweden

Study timelines

Date when funding contract was signed

Actual:25/04/2013

Study start date

Actual:24/07/2014

Data analysis start date

Planned:12/06/2017

Actual:30/05/2017

Date of final study report

Planned:27/11/2017

Actual:27/11/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

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)