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

NCT ID: NCT01685424

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2015-03-01

Brief Summary

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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).

Detailed Description

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Conditions

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Osteoarthritis Rheumatoid Arthritis Ankylosing Spondylitis Gout Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Etoricoxib Prescription (Period 1)

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

Etoricoxib

Intervention Type DRUG

As per routine clinical practice in the United Kingdom

Etoricoxib Prescription (Period 2)

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

Etoricoxib

Intervention Type DRUG

As per routine clinical practice in the United Kingdom

Repeat Etoricoxib Prescription

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

Etoricoxib

Intervention Type DRUG

As per routine clinical practice in the United Kingdom

Interventions

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Etoricoxib

As per routine clinical practice in the United Kingdom

Intervention Type DRUG

Other Intervention Names

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ARCOXIA®)

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Related Links

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Other Identifiers

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7013.021

Identifier Type: OTHER

Identifier Source: secondary_id

EMEA/H/A - 31/632

Identifier Type: OTHER

Identifier Source: secondary_id

0663-162

Identifier Type: -

Identifier Source: org_study_id

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