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

Phase 3CompletedNCT00542087

Organon and Co516 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

516

Conditions

Osteoarthritis

Interventions

MK0663, etoricoxib / Duration of Treatment: 6 WeeksDRUG

Comparator: diclofenac sodium / Duration of Treatment: 6 WeeksDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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