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

February 7, 2022 updated by: Organon and Co

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

79189

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All participants 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Etoricoxib Prescription (Period 1)
First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005
Drug: Etoricoxib
As per routine clinical practice in the United Kingdom
Other Names:
  • ARCOXIA®)
Etoricoxib Prescription (Period 2)
First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015
Drug: Etoricoxib
As per routine clinical practice in the United Kingdom
Other Names:
  • ARCOXIA®)
Repeat Etoricoxib Prescription
One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.
Drug: Etoricoxib
As per routine clinical practice in the United Kingdom
Other Names:
  • ARCOXIA®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose of Initial Etoricoxib Prescription
Time Frame: At first prescription (during a time period up to 13.75 years)
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)
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)
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
During a time period up to 13.75 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2006

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (ESTIMATE)

September 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0663-162
  • 7013.021 (OTHER: Study Identification Number)
  • EMEA/H/A - 31/632 (OTHER: Regulatory identifier)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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