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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: MK0663, etoricoxib / Duration of Treatment: 6 Weeks; Drug: Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
The study drug will be safe and well tolerated during the course of the study.

Collaborators and Investigators

• Sponsor: Organon and Co
• Investigators: Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE; etoricoxib OA study group. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19(8):725-36. doi: 10.1185/030079903125002469. Erratum In: Curr Med Res Opin. 2004 Oct;20(10):1689.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2002
• Primary Completion (Actual): December 20, 2002
• Study Completion (Actual): December 20, 2002

Study Registration Dates

• First Submitted: October 5, 2007
• First Submitted That Met QC Criteria: October 5, 2007
• First Posted (Estimated): October 10, 2007

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Diclofenac; Etoricoxib
• Other Study ID Numbers: 0663-805; 2007_625

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis