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Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

NCT01077843 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27381

Last updated 2022-02-18

No results posted yet for this study

Summary

This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).

The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.

Conditions

Interventions

DRUG

Etoricoxib

Cox-2 inhibitor

DRUG

Other Cox-2 inhibitors

Cox-2 inhibitor

DRUG

Other Non-selective NSAIDs

Non-selective NSAID

OTHER

No anti-inflammatory treatment

No anti-inflammatory prescription

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-17
Primary Completion
2015-07-01
Completion
2015-07-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077843 on ClinicalTrials.gov