Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: 1.2% Sodium Hyaluronate; Buffered Saline
Intervention description: IA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27).; IA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 596.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of
      either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety
      for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium
      hyaluronate and be followed for another 26 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic osteoarthritis (OA) of target knee confirmed by American College of
             Rheumatology (ACR) Criteria.

          -  Pain due to OA in target knee present for at least 6 months.

          -  During Screening and Baseline visits, subjects will require a visual analog scale
             (VAS) score (100 mm) of ≥ 41 mm and ≤ 90 mm, recorded immediately following a 50-foot
             walk, AND at Baseline, cannot have decreased >10mm (improvement) from Screening.

          -  A bilateral standing anteroposterior (AP) X-ray confirming OA of the target knee.

          -  Ability and willingness to use only acetaminophen as the analgesic (rescue) study
             medication

          -  Ability to perform procedures required of the pain index evaluations (unassisted
             walking 50 feet on a flat surface and going up and down stairs).

          -  Willingness and ability to complete efficacy and safety questionnaires and ability to
             read and understand study instructions.

          -  Signed Subject Informed Consent Form

        Exclusion Criteria:

          -  Any major injury (including sports injuries) to the target knee within the prior 12
             months.

          -  Any surgery to the target knee, hip and contralateral hip within the prior 12 months.

          -  Major and minor articular procedures

          -  Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or
             psoriatic arthritis.

          -  Gout or calcium pyrophosphate (pseudogout) diseases of the target knee that have
             flared within the previous 6 months.

          -  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.

          -  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 previous
             6 months prior to study enrollment.

          -  Symptomatic OA of the hips, spine, or ankle, if it would interfere with the evaluation
             of the target knee.

          -  Known hypersensitivity to acetaminophen, sodium hyaluronate, or phosphate buffered
             saline solution.

          -  Women of childbearing potential who are pregnant, nursing, or planning to become
             pregnant, and those who do not agree to remain on an acceptable method of birth
             control throughout the entire study period.

          -  Recurrent medical history of 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.

          -  Current treatment or treatment within the previous 2 years prior to Screening for any
             malignancy unless specific written permission is provided by the Sponsor (excluding
             basal cell or squamous cell carcinoma of the skin).

          -  Chronic liver disease and active liver disease based on liver profile of aspartate
             aminotransferase (AST), alanine transaminase (ALT), and conjugated bilirubin >2 times
             the upper limit of normal.

          -  Renal insufficiency based on serum creatinine >2.0 mg/dL.

          -  Any clinically significant laboratory value based on clinical history that the
             Investigator feels may affect the study evaluation.

          -  Any intercurrent chronic disease or condition that may interfere with the completion
             of the 6-month (or 12-month) follow-up of the study, such as liver disease, severe
             coronary disease, drug abuse, disordered mental state, or other clinically significant
             condition.

          -  Current alcoholism, and/or any known current addiction to pain medications.

          -  Any clinically significant finding that would place the patient at health risk, impact
             the study, or affect the completion of the study.

          -  Any psychiatric illness that would prevent comprehension of the details and nature of
             the study.

          -  Participation in any experimental device study within 6 months prior to the Screening,
             or an experimental drug study within 1 month prior to the Screening