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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092703

Purpose

The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.

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

MedlinePlus related topics: Dietary Sodium Osteoarthritis

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 50 mg t.i.d. in Patients With Osteoarthritis

Further study details as provided by Merck:

Primary Outcome Measures:

Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.

Estimated Enrollment:	6000
Study Start Date:	October 2002

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:

Osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief

Exclusion Criteria:

Known allergies to the study drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092703

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Baraf HS, Fuentealba C, Greenwald M, Brzezicki J, O'Brien K, Soffer B, Polis A, Bird S, Kaur A, Curtis SP; EDGE Study Group. Gastrointestinal side effects of etoricoxib in patients with osteoarthritis: results of the Etoricoxib versus Diclofenac Sodium Gastrointestinal Tolerability and Effectiveness (EDGE) trial. J Rheumatol. 2007 Feb;34(2):408-20.

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_052
Study First Received:	September 23, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00092703
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis

Etoricoxib
Diclofenac
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
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