An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: 4 mL injection of Ampion; 10 mL Injection of Ampion; 4 mL Injection of Placebo; 10 mL Injection of Placebo
Intervention description: 4 mL Injection of Ampion; 10 mL Injection of Ampion; 4 mL Injection of Placebo; 10 mL Injection of Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 329.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: osteoarthritis; osteoarthritis of the knee

Summary:

      This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in
      Adults with pain due to osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written informed consent to participate in the study

          -  Willing and able to comply with all study requirements and instructions of the site
             study staff

          -  Male or female, 40 years to 85 years old (inclusive)

          -  Must be ambulatory

          -  Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of
             osteoarthritis (OA) and supported by radiological evidence Kellgren Lawrence Grade II
             to IV) that is not older than 6 months prior to the date of screening

          -  Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the
             WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at screening

          -  Moderate to moderately-severe OA pain in the index knee (even if chronic doses of
             nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks
             prior to screening, have been/are being used)

          -  No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an
             efficacy measure

          -  No known clinically significant liver abnormality e.g. cirrhosis, transplant, etc.)

        Exclusion Criteria:

          -  As a result of medical review and screening investigation, the Principal Investigator
             considers the patient unfit for the study

          -  A history of allergic reactions to human albumin (reaction to non-human albumin such
             as egg albumin is not an exclusion criterion)

          -  A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan,
             sodium caprylate)

          -  Presence of tense effusions

          -  Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or
             joint replacement in the affected knee, as assessed locally by the Principal
             Investigator

          -  Isolated patella femoral syndrome, also known as chondromalacia

          -  Any other disease or condition interfering with the free use and evaluation of the
             index knee for the duration of the trial e.g. cancer, congenital defects, spine OA)

          -  Major injury to the index knee within the 12 months prior to screening

          -  Severe hip OA ipsilateral to the index knee

          -  Any pain that could interfere with the assessment of index knee pain (e.g. pain in any
             other part of the lower extremities, pain radiating to the knee)

          -  Any pharmacological or non-pharmacological treatment targeting OA started or changed
             during the 4 weeks prior to randomization or likely to be changed during the duration
             of the study

          -  Use of the following medications:

               1. No IA injected pain medications in the study knee during the study

               2. No analgesics containing opioids. NSAIDs may be continued at levels preceding the
                  study and acetaminophen is available as a rescue medication during the study from
                  the provided supply

               3. No topical treatment on osteoarthritis index knee during the study

               4. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
                  (treatment such as Aspirin and Plavix are allowed)

               5. No systemic treatments that may interfere with safety or efficacy assessments
                  during the study

               6. No immunosuppressants

               7. No use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg
                  prednisolone, the dose must be stable)

          -  Any human albumin treatment in the 3 months before randomization