Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

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. Identifier: NCT00542087
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : April 10, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: MK0663, etoricoxib / Duration of Treatment: 6 Weeks Drug: Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip
Actual Study Start Date : March 22, 2002
Actual Primary Completion Date : December 20, 2002
Actual Study Completion Date : December 20, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

Secondary Outcome Measures :
  1. The study drug will be safe and well tolerated during the course of the study.

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:

  • Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
  • Has a history of treatment with NSAIDs with positive therapeutic benefit
  • Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
  • Females who are able to have children must have negative urine pregnancy tests

Exclusion Criteria:

  • Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
  • History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
  • Requires joint replacement

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 identifier (NCT number): NCT00542087

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

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00542087     History of Changes
Obsolete Identifiers: NCT00092794
Other Study ID Numbers: 0663-805
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

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