Clinical trial: An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee. (NCT00240799)

Eligibility criteria:
Inclusion Criteria:

          -  Symptoms of osteoarthritis of the hip or knee for a minimum of six months

          -  History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs,
             acetaminophen or another analgesic agent on a regular basis (>= three days/week) for
             at least three months before the screening visit

          -  History of positive benefit with acetaminophen use for osteoarthritis pain

          -  History (ie, at any time in the past since diagnosis) of osteoarthritis pain of the
             hip or knee when not taking osteoarthritis analgesic medication

          -  Subjects must report a history of a pain level of moderate, moderately severe, or
             severe, a WOMAC pain score >= 65 at baseline, and a 20% or greater increase in their
             pain score relative to their score at screening

        Exclusion Criteria:

          -  History of surgery, including arthroscopy, or major trauma to the study joint in the
             previous six months before the screening visit

          -  Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence
             radiographic criteria

          -  Signs of clinically important active inflammation of the study knee joint including
             redness, warmth, and/or a large, bulging effusion with the loss of normal contour at
             the screening and/or baseline visits

          -  Secondary osteoarthritis of the study joint including, but not limited to, septic
             arthritis, inflammatory joint disease, gout, Paget's disease of bone, articular
             fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly,
             hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis

          -  History of acute inflammatory arthritis or pseudogout of the study joint.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Contradiction