Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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 purpose of this study is to compare the gastrointestinal tolerability of an
investigational drug to an approved drug in the treatment of osteoarthritis during one year
treatment period.
Clinical Details
Official title: A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 50 mg t.i.d. in Patients With Osteoarthritis
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Primary outcome: Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.
Detailed description:
The duration of treatment is 12 months.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Osteoarthritis of the knee, hip, hand or spine which requires the use of medications
for pain relief
Exclusion Criteria:
- Known allergies to the study drugs
Locations and Contacts
Additional Information
Related publications: Baraf HS, Fuentealba C, Greenwald M, Brzezicki J, O'Brien K, Soffer B, Polis A, Bird S, Kaur A, Curtis SP; EDGE Study Group. Gastrointestinal side effects of etoricoxib in patients with osteoarthritis: results of the Etoricoxib versus Diclofenac Sodium Gastrointestinal Tolerability and Effectiveness (EDGE) trial. J Rheumatol. 2007 Feb;34(2):408-20. 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: October 2002
Last updated: October 8, 2007
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