Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis

This study has been completed.

First Received on September 23, 2004. Last Updated on January 21, 2010 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092742

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: MK0663, etoricoxib Drug: Comparator: Diclofenac sodium	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Etoricoxib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Discontinuations due to clinical and laboratory gastrointestinal adverse experiences

Estimated Enrollment:	4000
Study Start Date:	February 2003

Detailed Description:

The duration of treatment is 12 months.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092742

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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.

Krueger K, Lino L, Dore R, Radominski S, Zhang Y, Kaur A, Simpson R, Curtis S. Gastrointestinal tolerability of etoricoxib in rheumatoid arthritis patients: results of the etoricoxib vs diclofenac sodium gastrointestinal tolerability and effectiveness trial (EDGE-II). Ann Rheum Dis. 2008 Mar;67(3):315-22. Epub 2007 Oct 27. Erratum in: Ann Rheum Dis.2008 May;67(5):732.

Krum H, Curtis SP, Kaur A, Wang H, Smugar SS, Weir MR, Laine L, Brater DC, Cannon CP. Baseline factors associated with congestive heart failure in patients receiving etoricoxib or diclofenac: multivariate analysis of the MEDAL program. Eur J Heart Fail. 2009 Apr 19; [Epub ahead of print]

Laine L, Curtis SP, Langman M, Jensen DM, Cryer B, Kaur A, Cannon CP. Lower gastrointestinal events in a double-blind trial of the cyclo-oxygenase-2 selective inhibitor etoricoxib and the traditional nonsteroidal anti-inflammatory drug diclofenac. Gastroenterology. 2008 Nov;135(5):1517-25. Epub 2008 Aug 3.

Laine L, Goldkind L, Curtis SP, Connors LG, Yanqiong Z, Cannon CP. How common is diclofenac-associated liver injury? Analysis of 17,289 arthritis patients in a long-term prospective clinical trial. Am J Gastroenterol. 2009 Feb;104(2):356-62. Epub 2009 Jan 27.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092742 History of Changes
Other Study ID Numbers:	2004_055, MK0663-072
Study First Received:	September 23, 2004
Last Updated:	January 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Diclofenac
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012