A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)
Information source: Merck
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis,Osteoarthritis
Intervention: MK0663, etoricoxib (Drug); Comparator: Diclofenac sodium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The study is designed to compare the risk of cardiovascular events (heart attacks, strokes)
in patients receiving either etoricoxib or diclofenac. It will also compare the
gastrointestinal tolerability of the two medicines. The study will be conducted in patients
with either rheumatoid or osteo-arthritis.
Clinical Details
Official title: A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid Arthritis
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Primary outcome: Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences based on combined data from this trial and MK0663 Protocols 061 & 072 (GI Tolerability in OA Patients and GI Tolerability Study in RA Patients ), respectively.
Secondary outcome: Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences from this trial alone. Gastrointestinal tolerability based on the percentage of patients that discontinue for clinical or laboratory gastrointesinal adverse experiences.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in
the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or
COX-2 inhibitor therapy for at least 1. 5 years
Exclusion Criteria:
Concurrent medical or arthritic disease that could confound or interfere with efficacy
evaluation.
Concomintant therapy of warfarin, heparin, high-dose aspirin (>100 mg/day).
Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure
with symptoms that occur at rest, unstable angina, uncontolled high blood pressure, active
hepatitis/hepatic disease
Locations and Contacts
Additional Information
Related publications: Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, Reicin AS, Bombardier C, Weinblatt ME, van der Heijde D, Erdmann E, Laine L; MEDAL Steering Committee. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet. 2006 Nov 18;368(9549):1771-81.
Starting date: September 2002
Last updated: May 17, 2007
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