Clinical trial: An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee (NCT00240786)

Eligibility criteria:
Inclusion Criteria:

          -  Symptomats 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 per week)
             for at least three months before the screening visit

          -  History of positive therapeutic benefit with acetaminophen use for osteoarthritis pain

          -  History of osteoarthritis pain (moderate, moderately severe, or severe) of the hip or
             knee when not taking osteoarthritis analgesic medication

          -  Must have a pain level of moderate or moderately severe for 24 hours over the previous
             24 hours prior to the baseline visit, and at baseline, demonstrate a 20% or greater
             increase in the pain subscale score, relative to the 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

          -  Maximum osteoarthritis pain intensity of none, mild or severe experienced over the
             previous 24 hours of the baseline visit

          -  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
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? Entailment