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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00542087
First received: October 5, 2007
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

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

Enrollment: 516
Study Start Date: March 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542087

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00542087     History of Changes
Obsolete Identifiers: NCT00092794
Other Study ID Numbers: 0663-805, 2007_625
Study First Received: October 5, 2007
Last Updated: February 4, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014