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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685424
• Other study ID #: 0663-162
• Secondary ID: 7013.021EMEA/H/A
• Status: Completed
• Start date: June 30, 2006
• Est. completion date: March 1, 2015

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79189
• Est. completion date: March 1, 2015
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Rheumatoid
• Gout
• Osteoarthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Etoricoxib
As per routine clinical practice in the United Kingdom

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of Initial Etoricoxib Prescription		At first prescription (during a time period up to 13.75 years)
Primary	Duration of Initial Etoricoxib Prescription		At first prescription (during a time period up to 13.75 years)
Primary	Participant's Baseline Characteristics (Demographics and Medical)		At first prescription (during a time period up to 13.75 years)
Primary	Incidence of Adverse Events of Special Interest Among Etoricoxib Users		During a time period up to 13.75 years
Secondary	"Off-label" use of Etoricoxib		At first prescription (during a time period up to 13.75 years)

External Links

•   EU PAS Register (EUPAS17526)