['osteoarthritis of the knee']
['fx006', 'placebo', 'tca ir 40']

        Inclusion Criteria:

          -  Willingness and ability to comply with the study procedures and visit schedules and
             ability to follow verbal and written instructions

          -  Male or female >=40 years of age

          -  Has symptoms associated with OA of the index knee for at least 6 months prior to
             Screening

          -  Currently meets American College of Rheumatology (ACR) Criteria (clinical and
             radiological) for OA

          -  Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray

          -  Index knee pain for > 15 days over the last month

          -  Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Willingness to abstain from use of restricted medications

        Exclusion Criteria:

          -  Any condition that could possibly confound the patient's assessment of index knee pain
             in judgement of the investigator (i.e., iIpsilateral hip OA, gout, 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 or greater than
             the index knee pain)

          -  Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
             spondylitis, arthritis associated with inflammatory bowel disease

          -  History of infection in the index knee

          -  Clinical signs and symptoms of active knee infection or crystal disease of the index
             knee within 1 month of Screening

          -  Unstable joint within 12 months of screening

          -  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) or oral corticosteroids (investigational or marketed) within 1
             month 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
      