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

Organon and Co1,167 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,167

Conditions

Osteoarthritis

Interventions

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 weeksDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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