A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)

Merck Sharp & Dohme LLC150 enrolled

Overview

This study is being conducted to assess the safety and tolerability of MK-0686 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

150

Conditions

Osteoarthritis

Interventions

MK0686DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 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 ARA functional class I,II or III and with no clinically significant diseases * 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 * females must be either post-menopausal or surgically sterilized Exclusion Criteria: * No history of concurrent arthritic disease * No history of neoplastic disease within a specified duration * No history of disease that causes malabsorption * Chronic use of certain medications excluded

Outcomes

Primary Outcomes

Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.

Time frame: over 4 weeks of treatment

Secondary Outcomes

Safety and tolerability over a 4-week treatment period

Time frame: over a 4-week treatment period

Data from ClinicalTrials.gov

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