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

Completed

• Conditions: Osteoarthritis; Ankylosing Spondylitis; Gout; Arthritis; Rheumatoid Arthritis
• Interventions: Drug: Etoricoxib

• Registration Number: NCT01685424
• Lead Sponsor: Organon and Co

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-30
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-14
• Primary Completion: 2015-03-01
• Study Completion: 2015-03-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79189

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dose of Initial Etoricoxib Prescription	At first prescription (during a time period up to 13.75 years)
Duration of Initial Etoricoxib Prescription	At 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 Users	During a time period up to 13.75 years

Secondary Outcome Measures

Name	Time	Method
"Off-label" use of Etoricoxib	At first prescription (during a time period up to 13.75 years)