An Investigational Drug in Patients With Osteoarthritis of the Knee or Hip

This study has been completed.

First Received: September 23, 2004 Last Updated: September 5, 2006 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092794

Purpose

The purpose of this study is to compare the safety and efficacy of an investigational medication to an approved drug in the treatment of osteoarthritis of the knee or hip in patients who continue to have pain after stopping current medications.

Condition	Intervention	Phase
Osteoarthritis	Drug: MK0663, etoricoxib Drug: Comparator: diclofenac	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 Patients 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:

Efficacy in the treatment of osteoarthritis of the knee or hip during a six week treatment period as assessed by the WOMAC pain subscale.

Secondary Outcome Measures:

Safety and tolerability.

Estimated Enrollment:	500
Study Start Date:	March 2002

Detailed Description:

The duration of treatment is 6 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Male/female patients at least 40 years of age with a diagnosis of osteoarthritis of the knee or hip who continue to have pain after stopping current medication.

Exclusion Criteria:

Any known allergy to the study drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092794

Locations

United States, Pennsylvania
Call for International Site Information
Horsham, Pennsylvania, United States, 19044

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.

Study ID Numbers:	2004_059
Study First Received:	September 23, 2004
Last Updated:	September 5, 2006
ClinicalTrials.gov Identifier:	NCT00092794 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Additional relevant MeSH terms:

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

Osteoarthritis, Knee
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 08, 2010