a study to evaluate the efficacy & safety of an intra-articular ampion injection for pain of osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: this study will evaluate the efficacy and safety of an intra-articular injection of ampion™ in adults with pain due to osteoarthritis of the knee

a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an intra-articular injection of ampion™ in adults with pain due to osteoarthritis of the knee the primary trial objective is to evaluate the efficacy of 4 ml of ampion™ versus 4 ml placebo intra-articular (ia) injection in improving knee pain, when applied to patients suffering from oa of the knee. the secondary trial objective is evaluation of the safety of an intra-articular injection of ampion™.

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 oa and supported by radiological evidence (kellgren lawrence grade ii, iii, or iv) read by a central reader; * womac 5-point likert pain subscale \<1.5 in the contralateral knee; * 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); * 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); * ability to discontinue nsaid use at screening visit and/or 72 hours prior to the baseline visit and for the duration of the clinical study (low dose aspirin is allowed during the study); * no analgesia (including acetaminophen \[paracetamol\]) taken 24 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 osteoarthritis) * major injury to the index knee within the 12 months prior to screening * severe hip osteoarthritis 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 * pregnancy or planning to become pregnant during the study. * use of the following medications: * no ia injected pain medications in the study knee during the study * no analgesics containing opioids. * nsaids are not permitted during the study; acetaminophen is available as a rescue medication during the study from the provided supply. * no topical treatment on osteoarthritis index knee during the study * no significant anticoagulant therapy (e.g. heparin or lovenox) during the study (treatment such as low dose aspirin and plavix are allowed) * no systemic treatments that may interfere with safety or efficacy assessments during the study * no immunosuppressants * no use of corticosteroids * no human albumin treatment in the 3 months before randomization or throughout the duration of the study

Keywords: osteoarthritis osteoarthritis of the knee