Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED) - 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 3


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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

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.

Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP; MEDAL Steering Committee. Assessment of upper gastrointestinal safety of 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. 2007 Feb 10;369(9560):465-73.

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 Jun;11(6):542-50. doi: 10.1093/eurjhf/hfp054. Epub 2009 Apr 19.

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. doi: 10.1053/j.gastro.2008.07.067. 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. doi: 10.1038/ajg.2008.149. Epub 2009 Jan 27.


Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092703 History of Changes
Other Study ID Numbers:	2004_052, MK0663-061
Study First Received:	September 23, 2004
Last Updated:	May 21, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


Arcoxia

Additional relevant MeSH terms:


Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Diclofenac Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal	Antirheumatic Agents Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015