Patient description: A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.

Clinical trial eligibility criteria: eligible ages (years): 40.0-76.0,  Osteoarthritis of the Knee Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to entry into the Screening Period (Day -3) Subject has OA pain of the Target Knee with a WOMAC Pain Subscale baseline value of > 9 at the Baseline/Randomization Period (Maximum score is 20 for 5 questions with 0 = none; 4 = extreme Subject must have a Functional Capacity Classification of I-III Subject has taken a stable dose of NSAIDs or COX-2 inhibitor agents for OA pain for at least 22 of the previous 28 days and for each of the 2 days prior to the Screening Period (Day -3) and for at least each of the 2 days prior to the Baseline/Randomization Period (Day 1). Subject must also, agree and be expected to remain on this stable daily dose throughout the study Subject is between 40-75 years of age Diagnosis of OA is present for at least 6 months according to the ACR for OA of the knee Radiographic evidence of OA of the Target Knee (within the last 3 years) with a Kellgren-Lawrence scale of 2 or 3 Subject is generally in good health Subject is expected to be compliant with study procedures Females of child-bearing potential must have a negative urine pregnancy test at Screening  Presence of tendonitis, bursitis, partial or complete joint replacement of Target Knee Presence of active skin disease, erythema, infection, wound or irritation near the treatment area of the Target Knee Subject has history of frequent headache or other painful conditions (other than OA) that is expected to require any use of systemic opiates or derivatives, or more than twice a week additional administration of different oral NSAIDs or COX-2 inhibitors (see Section 6.1, Table 2) Subject experiences regular significant pain due to osteoarthritis or other conditions in the non-target knee or other joints while on stable doses of their current analgesic therapy Subject has an anticipated need for any surgical or other invasive procedure that will be performed on the Target Knee or other part of the body during the course of the study OA secondary to local joint disorders (e.g., mechanical disorder, internal derangement of the knee), systemic metabolic disease, endocrine disorders, bony dysplasia, calcium crystal deposition disease, neuropathic arthropathy, frostbite, congenital abnormalities Subject has history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease Subject has active (redness, swelling, fever, etc.) gout/pseudogout within 6 months prior to screening Subject has Type I or Type II diabetes with peripheral neuropathies Subject is extremely obese with BMI ≥ 39