Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
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 evaluate the long-term safety of an investigational drug
versus an approved drug for the relief of pain in patients with rheumatoid arthritis.
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 75 mg b.i.d. in Patients With Rheumatoid Arthritis
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Primary outcome: Discontinuations due to clinical and laboratory gastrointestinal adverse experiences
Detailed description:
The duration of treatment is 12 months.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females 50 years or older with rheumatoid arthritis.
Exclusion Criteria:
- History of gastrointestinal malabsorption or inflammatory bowel disease
- History of heart problems such as: congestive heart failure (CHF), heart attack or
high blood pressure.
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: February 2003
Last updated: October 8, 2007
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