Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis - Full Text View

Sponsored by:	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

MedlinePlus related topics: Dietary Sodium Rheumatoid Arthritis

Drug Information available for: Diclofenac Diclofenac potassium Diclofenac sodium Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
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

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.

Publications indexed to this study:

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.

Study ID Numbers:	2004_055
Study First Received:	September 23, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00092742
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Etoricoxib

Connective Tissue Diseases
Arthritis, Rheumatoid
Diclofenac
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009