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Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 18, 2005
Last updated: February 24, 2015
Last verified: February 2015
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.

Condition Intervention Phase
Osteoarthritis Drug: MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks) Drug: Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.

Resource links provided by NLM:

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

Primary Outcome Measures:
  • WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)

Secondary Outcome Measures:
  • Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy

Enrollment: 1167
Study Start Date: June 1998
Study Completion Date: July 2002
Primary Completion Date: February 1999 (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:

  • At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
  • Positive therapeutic effect from prior NSAID therapy.
  • Worsening of symptoms upon withdrawal of prior treatment.
  • With the exception of OA, in otherwise good health

Exclusion Criteria:

  • Weight no more than 280 pounds (male or female).
  • Recent, sustained use of gastroprotective agents.
  • History of arthroscopy of the affected knee within 6 months prior to study entry.
  • History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00242489

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00242489     History of Changes
Other Study ID Numbers: 0663-007
Study First Received: October 18, 2005
Last Updated: February 24, 2015

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 June 23, 2017