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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT01685424
• Date of registration: 23/08/2012
• Prospective Registration: No
• Primary sponsor: Organon and Co
• Public title: Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)
• Scientific title: Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis
• Date of first enrolment: June 30, 2006
• Target sample size: 79189
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01685424
• Study type: Observational

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis

Gout

Rheumatoid Arthritis

Ankylosing Spondylitis

Arthritis

Intervention(s)

Drug: Etoricoxib

Primary Outcome(s)

Duration of Initial Etoricoxib Prescription [Time Frame: At first prescription (during a time period up to 13.75 years)]

Dose of Initial Etoricoxib Prescription [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]

Participant's Baseline Characteristics (Demographics and Medical) [Time Frame: At first prescription (during a time period up to 13.75 years)]

Secondary Outcome(s)

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

Secondary ID(s)

7013.021

0663-162

EMEA/H/A - 31/632

Source(s) of Monetary Support

Please refer to primary and secondary sponsors