A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA) - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00250445

Purpose

The study is designed to compare the risk of cardiovascular events (heart attacks, strokes) in patients receiving either etoricoxib or diclofenac. It will also compare the gastrointestinal tolerability of the two medicines. The study will be conducted in patients with either rheumatoid or osteo-arthritis.

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

MedlinePlus related topics: Osteoarthritis 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, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid Arthritis

Further study details as provided by Merck:

Primary Outcome Measures:

Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences based on combined data from this trial and MK0663 Protocols 061 & 072 (GI Tolerability in OA Patients and GI Tolerability Study in RA Patients ), respectively.

Secondary Outcome Measures:

Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences from this trial alone. Gastrointestinal tolerability based on the percentage of patients that discontinue for clinical or laboratory gastrointesinal adverse experiences.

Estimated Enrollment:	23500
Study Start Date:	September 2002

Eligibility

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

Criteria

Inclusion Criteria:

Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or COX-2 inhibitor therapy for at least 1.5 years

Exclusion Criteria:

Concurrent medical or arthritic disease that could confound or interfere with efficacy evaluation.
Concomintant therapy of warfarin, heparin, high-dose aspirin (>100 mg/day).
Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure with symptoms that occur at rest, unstable angina, uncontolled high blood pressure, active hepatitis/hepatic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250445

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:	2005_100
Study First Received:	November 7, 2005
Last Updated:	May 17, 2007
ClinicalTrials.gov Identifier:	NCT00250445
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
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 16, 2009