Clinical trial: A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee (NCT00240773)

Eligibility criteria:
Inclusion Criteria:

          -  Osteoarthritis of the hip or 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

          -  History of osteoarthritis of the hip or knee characterized by pain of mild or moderate
             intensity

          -  Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and
             Lawrence radiographic entry criteria

          -  Physical ability must be either American College of Rheumatology (ACR) Functional
             Class I or II

          -  Following the washout period, reports mild to moderately severe pain over the previous
             24 hours and demonstrates a minimum increase of 20% in the WOMAC Osteoarthritis Index
             pain subscale score, relative to the screening score.

        Exclusion Criteria:

          -  History of surgery, including arthroscopy, or major trauma to the study joint in the
             previous 12 months

          -  Radiographic evidence of severe osteoarthritis of the study joint based on the
             Kellgren and Lawrence radiographic criteria of grade 4 osteoarthritis

          -  Signs of active study joint inflammation including redness, warmth, and/or, if
             qualifying with osteoarthritis of the knee, a large, bulging effusion of the study
             knee joint with the loss of normal contour of the joint at the screening visit or at
             the baseline examination after the washout period

          -  Morning stiffness of >30 minutes duration

          -  Significantly incapacitated or disabled and would be categorized as ACR Functional
             Class III (able to perform only few or none of the duties of usual occupation or
             self-care) or IV (largely or wholly incapacitated), or unable to walk without
             assistive devices
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.
Subject must be at most 75 Years

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