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Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)

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Organon

Status

Completed

Conditions

Osteoarthritis
Arthritis
Ankylosing Spondylitis
Gout
Rheumatoid Arthritis

Treatments

Drug: Etoricoxib

Study type

Observational

Funder types

Industry

Identifiers

NCT01685424
EMEA/H/A - 31/632 (Other Identifier)
0663-162
7013.021 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

79,189 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.

Exclusion criteria

  • Not registered in a GPRD-contributing practice that had continuously

collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December 2015.

  • Never registered as a permanent patient of a General Practitioner in the practice
  • Registration details were not acceptable (i.e. incomplete data or logically implausible dates)
  • Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD

Trial design

79,189 participants in 3 patient groups

Etoricoxib Prescription (Period 1)
Description:
First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005
Treatment:
Drug: Etoricoxib
Etoricoxib Prescription (Period 2)
Description:
First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015
Treatment:
Drug: Etoricoxib
Repeat Etoricoxib Prescription
Description:
One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.
Treatment:
Drug: Etoricoxib

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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