Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

Exclusion Criteria

• •Ipsilateral hip OA
• •Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
• •History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
• •History of arthritides due to crystals (e.g., gout, pseudogout)
• •History or clinical signs and symptoms of infection in the index joint
• •Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)
• •Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
• •IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
• •IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• •Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
• •Oral corticosteroids (investigational or marketed) within 1 month of Screening
• •Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
• •Any other IA investigational drug/biologic within 6 months of Screening
• •Prior use of FX006
• •Women of child-bearing potential not using effective contraception or who are pregnant or nursing