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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01685424
First received: August 23, 2012
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Gout
Arthritis
Drug: Etoricoxib

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Dose of Initial Etoricoxib Prescription [ Time Frame: At first prescription (during a time period up to 13.75 years) ] [ Designated as safety issue: No ]
  • Duration of Initial Etoricoxib Prescription [ Time Frame: At first prescription (during a time period up to 13.75 years) ] [ Designated as safety issue: No ]
  • Participant's Baseline Characteristics (Demographics and Medical) [ Time Frame: At first prescription (during a time period up to 13.75 years) ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events of Special Interest Among Etoricoxib Users [ Time Frame: During a time period up to 13.75 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • "Off-label" use of Etoricoxib [ Time Frame: At first prescription (during a time period up to 13.75 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30000
Study Start Date: June 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: ARCOXIA®)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01685424     History of Changes
Other Study ID Numbers: 0663-162, 7013.021, EMEA/H/A - 31/632
Study First Received: August 23, 2012
Last Updated: September 12, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Etoricoxib
ARCOXIA
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Gout
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014