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

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:

Osteoarthritis

ChemIDplus related topics:

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.

Study ID Numbers:	2004_052
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 October 09, 2008

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