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...
Date First Received: September 23, 2004
Last Updated: October 8, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 3 | Start Date: February 2003
Overall Status: Completed
Estimated Enrollment: 4000
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Detailed Clinical Trial Description
The duration of treatment is 12 months.
Intervention(s) in this Clinical Trial
- Drug: MK0663, etoricoxib
- Drug: Comparator: Diclofenac sodium
Outcome Measures for this Clinical Trial
Primary Measures
- Discontinuations due to clinical and laboratory gastrointestinal adverse experiences
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092742
Study ID Number: 2004_055
ClinicalTrials.gov Identifier: NCT00092742
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
