Clinical trial: HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain (NCT00792727)

Eligibility criteria:
Inclusion Criteria:

          -  man or woman ≥45 years of age.

          -  clinical diagnosis of unilateral or bilateral OA of the knee

          -  taking an NSAID or acetaminophen on a regular basis and has a history of knee pain
             amelioration with NSAID or acetaminophen use.

          -  mild to moderate OA of the knee at the screening visit

          -  subject exhibits an arthritis "flare" in the target knee within 7 days day of
             withdrawing from a NSAID or acetaminophen.

          -  subject understands that treatment will be administered on an inpatient basis.

          -  subject is capable of understanding and complying with the protocol and has signed the
             informed consent document.

        Exclusion Criteria:

          -  subject is a woman of childbearing potential who has a positive urine pregnancy test,
             is lactating, or who is not surgically sterile

          -  subject has symptoms that are attributable to primary inflammatory diseases of the
             joint

          -  subject has unstable knees including a history of the knee catching or giving way or
             physical examination evidence of instability

          -  subject has arthropathies that occur in conjunction with systemic diseases

          -  subject has a chronic pain condition

          -  subject is grossly obese

          -  subject has a history of knee surgery within the past 12 months or arthroscopy within
             the past 6 months.

          -  subject has a history of osteotomies.

          -  subject is not willing to discontinue the use of NSAIDs, acetaminophen or other
             prohibited treatments

          -  subject used opioids for OA pain within 1 month
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1