Overview

This trial is active, not recruiting.

Conditions osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, gout, arthritis
Treatment etoricoxib
Phase phase 4
Sponsor Merck Sharp & Dohme Corp.
Start date June 2006
End date September 2017
Trial size 30000 participants
Trial identifier NCT01685424, 0663-162, 7013.021, EMEA/H/A - 31/632

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005
etoricoxib ARCOXIA®)
As per routine clinical practice in the United Kingdom
First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015
etoricoxib ARCOXIA®)
As per routine clinical practice in the United Kingdom
One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.
etoricoxib ARCOXIA®)
As per routine clinical practice in the United Kingdom

Primary Outcomes

Measure
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

Measure
"Off-label" use of Etoricoxib
time frame: At first prescription (during a time period up to 13.75 years)

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..