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

Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01685424
Enrollment
79189
Registered
2012-09-14
Start date
2006-06-30
Completion date
2015-03-01
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Arthritis, Gout, Osteoarthritis, Rheumatoid Arthritis

Keywords

Etoricoxib, ARCOXIA, Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout, Arthritis

Brief summary

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).

Interventions

DRUGEtoricoxib

As per routine clinical practice in the United Kingdom

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Dose of Initial Etoricoxib PrescriptionAt first prescription (during a time period up to 13.75 years)
Duration of Initial Etoricoxib PrescriptionAt first prescription (during a time period up to 13.75 years)
Participant's Baseline Characteristics (Demographics and Medical)At first prescription (during a time period up to 13.75 years)
Incidence of Adverse Events of Special Interest Among Etoricoxib UsersDuring a time period up to 13.75 years

Secondary

MeasureTime frame
Off-label use of EtoricoxibAt first prescription (during a time period up to 13.75 years)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026