Etoricoxib vs. Diclofenac in OA - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00542087

Purpose

To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

Condition	Intervention	Phase
Osteoarthritis	Drug: MK0663, etoricoxib / Duration of Treatment: 6 Weeks Drug: Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Etoricoxib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

Secondary Outcome Measures:

The study drug will be safe and well tolerated during the course of the study.

Estimated Enrollment:	500
Study Start Date:	May 2002
Study Completion Date:	December 2002

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
Has a history of treatment with NSAIDs with positive therapeutic benefit
Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
Females who are able to have children must have negative urine pregnancy tests

Exclusion Criteria:

Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
Requires joint replacement

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542087

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE; etoricoxib OA study group. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19(8):725-36.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_625
Study First Received:	October 5, 2007
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00542087 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Etoricoxib
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions

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

ClinicalTrials.gov processed this record on February 09, 2010