NCT01685424

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79,189

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2006

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

8.7 years

First QC Date

August 23, 2012

Last Update Submit

February 7, 2022

Conditions

OsteoarthritisRheumatoid ArthritisAnkylosing SpondylitisGoutArthritis

Keywords

EtoricoxibARCOXIAOsteoarthritisRheumatoid ArthritisAnkylosing SpondylitisGoutArthritis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • "Off-label" use of Etoricoxib

    At first prescription (during a time period up to 13.75 years)

Study Arms (3)

Etoricoxib Prescription (Period 1)

First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005

Drug: Etoricoxib

Etoricoxib Prescription (Period 2)

First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015

Drug: Etoricoxib

Repeat Etoricoxib Prescription

One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.

Drug: Etoricoxib

Interventions

EtoricoxibDRUG

As per routine clinical practice in the United Kingdom

Also known as: ARCOXIA®)
Etoricoxib Prescription (Period 1)Etoricoxib Prescription (Period 2)Repeat Etoricoxib Prescription

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidSpondylitis, AnkylosingGoutArthritis

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisCrystal ArthropathiesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 14, 2012

Study Start

June 30, 2006

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 18, 2022

Record last verified: 2022-02