Efficacy of Myalgesin™ to Support Joint Function in Patients With Knee Osteoarthritis

Inclusion Criteria: * Men and women age 50-years or older. * Patients with symptomatic osteoarthritis of the knees as defined by the American College of Rheumatology criteria(traditional format). * At least moderate pain in the knee (rated at 40 or greater by the subject on a visual analogue scale) for most days during the last month. * Use of analgesic or anti-inflammatory agents for control of pain for at least 1 month. * Baseline functional capacity class 1 to 3, in which class 1 is complete ability to carry out usual activities without handicap,class 2 is ability to adequately conduct usual activities despite handicap of discomfort or limited mobility of one or more joints,and class 3 is limited ability to carry out usual activities. (American Rheumatism Association functional class) * Documented radiographic changes of osteoarthritis on a previous knee radiograph (Kellgren-Lawrence grade of 2 or more). Exclusion Criteria: * Age \<50-years. * Body mass index (BMI) equal to or greater than 35 kg/m2. * Baseline functional class 4 with the subject bedridden or confined to wheelchair, largely or wholly incapacitated and capable of little or no self-care. (American Rheumatism Association functional class) * Inflammatory arthritis, gout, pseudogout, or Paget's disease. * Presence of chronic pain syndromes, such as fibromyalgia or reflex sympathetic dystrophy, that may interfere with the assessment of joint symptomatology. * Severe bursitis of the knee. * History of acute joint trauma within 30 days of study entry. * Complete loss of articular cartilage. * History of total knee replacement. * Intra-articular/intramuscular corticosteroids within 30 days of study entry. * Intra-articular hyaluronan and hyalans within 30 days of study entry. * History of gastrointestinal bleeding within 1 year of study entry. * Active peptic ulcer disease, gastroesophageal reflux disease, or inflammatory bowel disease. * Gastrointestinal tract ulceration within 30 days of study entry. * Severe renal dysfunction defined as a serum creatinine greater than 2 mg/dL. * Clinically significant liver disease including an aspartate aminotransferase or alanine aminotransferase \>2 times the upper limit of normal. * Unwillingness or inability to abstain from ethanol for the study duration. * Significant bleeding disorder. * History of gastric or duodenal surgery. * Warfarin use. * Sensitivity to acetaminophen or to any of the components of Myalgesin™. * Pregnancy. * Any serious medical, social or psychological condition that, in the opinion of the Principal Investigator, would disqualify a subject from participation.