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A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: December 21, 2005
Last updated: April 6, 2017
Last verified: April 2017
This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Condition Intervention Phase
Drug: MK0663, etoricoxib / Duration of Treatment 12 Weeks
Drug: Placebo or Ibuprofen / Duration of Treatment 12 Weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 1)

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.

Secondary Outcome Measures:
  • Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.

Enrollment: 528
Actual Study Start Date: February 5, 2003
Study Completion Date: November 21, 2003
Primary Completion Date: November 7, 2003 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
  • Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
  • Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
  • Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.

Exclusion Criteria:

  • No history of concurrent arthritic disease
  • uncontrolled hypertension or an active cardiac condition
  • No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.
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Please refer to this study by its identifier: NCT00269191

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

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00269191     History of Changes
Other Study ID Numbers: 0663-071
Study First Received: December 21, 2005
Last Updated: April 6, 2017

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017