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
Sponsored by: Merck
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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
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.
The duration of treatment is 12 months.
Minimum age: 50 Years.
Maximum age: N/A.
- Osteoarthritis of the knee, hip, hand or spine which requires the use of medications
for pain relief
- Known allergies to the study drugs
Locations and Contacts
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