Clinical trial: A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee (NCT00568295)

Eligibility criteria:
Inclusion Criteria:

          -  Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration
             requiring treatment with either an analgesic or anti-inflammatory agent on a regular
             basis (greater than or equal to three days/week) for at least three months.

          -  A history of osteoarthritis of the knee characterized by pain of at least a moderate
             intensity.

          -  Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the
             Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.

          -  Subjects' physical ability was to be either American College of Rheumatology (ACR)
             Function Class I or II

          -  At the baseline visit, subjects must have reported a maximum pain intensity
             experienced over the previous 24 hours of at least moderate on a five-point scale of
             none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be
             enrolled in the study.

        Exclusion Criteria:

          -  Medical history, physical examinations, or radiographs suggestive of other types of
             arthritis, pseudogout, collagen vascular disease or fibromyalgia.

          -  Medical or psychiatric conditions that may influence absorption, metabolism, or
             excretion of the study medications or interfere with interpretation of adverse
             reactions to the study drug.

          -  History of allergy, sensitivity, contraindication or non-response to acetaminophen,
             rofecoxib, or drugs classified as NSAIDs including aspirin.

          -  Use of concomitant medications that might interfere with study drug assessments,
             including intra-articular corticosteroids.

          -  Signs of active knee inflammation, morning stiffness of greater than 30 minutes
             duration.

          -  Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren
             erythrocyte sedimentation rate greater than or equal to 40 mm/hour.

          -  ACR functional class III or IV, or unable to walk without assistive devices.

          -  Pregnancy, lactation, or expect to become pregnant within one month of study
             completion.
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