Completed

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

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What is being collected

Drug Data

+ drug Data

+ drug Data

Collected from past medical records and data - Retrospective
Drug
Who is being recruted

Crystal Arthropathies+23

+ Axial Spondyloarthritis

+ Ankylosis

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2006
See protocol details

Summary

Principal SponsorOrganon and Co
Last updated: February 18, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2006

Actual date on which the first participant was enrolled.

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).

NCT01685424
Principal SponsorOrganon and Co
Last updated: February 18, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

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

79189 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crystal ArthropathiesAxial SpondyloarthritisAnkylosisAutoimmune DiseasesBone DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsRheumatic DiseasesSpinal DiseasesSpondylitisSkin and Connective Tissue DiseasesSpondylarthritisSpondylarthropathiesGenetic Diseases, InbornArthritisArthritis, RheumatoidGoutOsteoarthritisSpondylitis, Ankylosing

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers