A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)

Organon and Co528 enrolled

Overview

This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

528

Conditions

Osteoarthritis

Interventions

MK0663, etoricoxib / Duration of Treatment 12 WeeksDRUG

Placebo or Ibuprofen / Duration of Treatment 12 WeeksDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee * Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III * Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment * Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA. Exclusion Criteria: * No history of concurrent arthritic disease * uncontrolled hypertension or an active cardiac condition * No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.

Outcomes

Primary Outcomes

Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.

Secondary Outcomes

Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.

Data from ClinicalTrials.gov

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