A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee

• Chronic OA of target knee confirmed by American College of Rheumatology Criteria
• Pain due to OA in target knee that had been present for at least 6 months, with a moderate to severe pain score of >50 mm recorded on a 100 mm Visual Analogue Scale (VAS) following a 50-foot walk
• Subject agrees to discontinue all pain medications for at least 7 days prior to start of study
• A bilateral standing anteroposterior x-ray confirming Grade 2 or 3 OA of the target knee
• Body mass index ≤40kg/m2

• Able and willing to use only acetaminophen as the analgesic (rescue) study medication under the following conditions:

  • acetaminophen dose is not to exceed 4 grams (4000mg)/day
  • if the subject has known chronic liver disease, the maximum dose of acetaminophen is not to exceed 2 grams (2000 mg)/day
  • subject must be able and willing to discontinue acetaminophen at least 24 hours prior to all study-specific visits
• Ability to perform procedures required of the pain index evaluations (unassisted walking for a distance of 50 feet on a flat surface and going up and down stairs)
• Agrees to use a highly effective contraception
• Able and willing to complete effectiveness and safety questionnaires and able to read and understand study instructions

Exclusion Criteria:

• Any major injury to the target knee within the 12 months prior to the Screening and Enrollment Visit
• Any surgery to the target knee within the 12 months prior to the Screening and Enrollment Visit,
• Articular procedures such as transplants or ligament reconstruction to the target knee within 12 months prior to Screening and Enrollment Visit
• Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
• Gout or calcium pyrophosphate diseases of the target knee that have flared within the 6 months prior to the Screening and Enrollment Visit
• X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
• Osteonecrosis of either knee
• Clinical signs and symptoms of active knee infection or crystal disease of the target knee
• Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
• Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in the target knee
• Significant target knee joint, infection or skin disorder infection within the 6 months prior to study enrollment
• Symptomatic OA of the hips, spine, or ankle, that interferes with the evaluation of the target knee
• Known hypersensitivity to acetaminophen or any of the study medications or their components
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant
• History of recurrent severe allergic or immune mediated reactions or other immune disorders
• Vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere with the study evaluation
• Intra-arterial corticosteroid (investigational or marketed) in any joint within 3 months of Screening and Enrollment Visit
• Current treatment, or treatment within the 2 years prior to the Screening and Enrollment Visit, for any malignancy
• Active liver disease based on liver profile of aspartate aminotransferase, alanine aminotransferase, and conjugated bilirubin >2 times the upper limit of normal
• Renal insufficiency based on serum creatinine >2.0mg/dL
• Any intercurrent chronic disease or condition that might interfere with the completion of the study
• Current alcoholism and/or any known current addiction to pain medications
• Participation in any experimental device study within 6 months prior to the Screening and Enrollment Visit, or participation in an experimental drug study within 1 month prior to the Screening and Enrollment Visit.