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 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? Entailment