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An Investigational Drug in Patients With Osteoarthritis (0663-073)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00092755
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : April 10, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Drug: MK0663, etoricoxib Drug: Comparators: ibuprofen and placebo Phase 3

Detailed Description:
The duration of treatment is 12 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 548 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 9, 2003
Primary Completion Date : November 13, 2003
Study Completion Date : November 13, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092755

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092755     History of Changes
Other Study ID Numbers: 0663-073
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors