An Investigational Drug in Patients With Osteoarthritis - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092755

Purpose

This study was conducted to assess the safety and tolerability of an investigational drug and to evaluate its effectiveness in the treatment of osteoarthritis of the hip or knee in both men and women.

Condition	Intervention	Phase
Osteoarthritis	Drug: MK0663, etoricoxib Drug: Comparators: ibuprofen and placebo	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ibuprofen Dexibuprofen Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 2)

Further study details as provided by Merck:

Primary Outcome Measures:

WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status Scale. Efficacy data collected at Weeks 2, 4, 8, and 12.

Secondary Outcome Measures:

Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Womac VA 3.0: Stiffness, Overall Average Score and Overall Subscale Average. Clinical efficacy data collected at Weeks 2, 4, 8, and 12.

Estimated Enrollment:	500
Study Start Date:	April 2003

Detailed Description:

The duration of treatment is 12 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Patients with osteoarthritis of the hip or knee who use current approved medication (nonsteroidal anti-inflammatory drugs (NSAIDs)) or tylenol to treat the symptoms of their osteoarthritis. Patients taking NSAIDs are required to discontinue using these drugs and their symptoms must become worse.

Exclusion Criteria:

Patients with certain medical conditions may not be allowed to participate. These conditions will be reviewed with the study physician.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092755

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Puopolo A, Boice JA, Fidelholtz JL, Littlejohn TW, Miranda P, Berrocal A, Ko A, Cichanowitz N, Reicin AS. A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30mg and ibuprofen 2400mg for the treatment of patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Jul 13; [Epub ahead of print]

Study ID Numbers:	2004_056
Study First Received:	September 23, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00092755
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Study placed in the following topic categories:

Ibuprofen
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Etoricoxib
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