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

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).

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Key information

Conditions

Osteoarthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crystal Arthropathies Genetic Diseases, Inborn Gout Immune System Diseases Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etoricoxib

Drug

As per routine clinical practice in the United Kingdom

Other names: ARCOXIA®)

Primary outcomes

Dose of Initial Etoricoxib Prescription

Time frame: At first prescription (during a time period up to 13.75 years)
Duration of Initial Etoricoxib Prescription

Time frame: At first prescription (during a time period up to 13.75 years)
Participant's Baseline Characteristics (Demographics and Medical)

Time frame: At first prescription (during a time period up to 13.75 years)
Incidence of Adverse Events of Special Interest Among Etoricoxib Users

Time frame: During a time period up to 13.75 years

Secondary outcomes

"Off-label" use of Etoricoxib

Time frame: At first prescription (during a time period up to 13.75 years)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2015
Study completion: 2015
First posted: Sep 14, 2012
Registry last updated: Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed