Clinical trial: Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee (NCT00317733)

Eligibility criteria:
Inclusion Criteria:

          -  Osteoarthritis of the knee for a minimum of six months

          -  Patient´s rating of pain in the index knee while not taking oral NSAIDs of at least 3
             using a 5-point Likert scale

          -  Presenting two out of the three following criteria - Morning stiffness of less than 30
             minutes duration, Crepitus on motion, Age >= 40 years

          -  Patients must have used oral NSAIDs at least 3 days per week for the 3 months prior to
             screening or the patient was taking an NSAID on a regular basis (>25 out of 30 days)
             at a therapeutic level for at least 30 days prior to screening

          -  Each of the following three criteria (the osteoarthritis flare criteria) must be met -
             Index knee pain assessment at walking at least 40 mm on VAS at baseline, Increase of
             index knee pain at walking by at least 15 mm on VAS at baseline compared to screening,
             Physician´s global assessment of osteoarthritis 3-5 and at least 1 grade increase from
             screening

        Exclusion Criteria:

          -  Grade 1 or Grade 4 severity of the index knee based on Kellgren and Lawrence
             radiographic criteria

          -  Intraarticular injections or arthroscopy of the index knee within 3 months prior to
             screening

          -  Signs of any clinically important inflammation of the index knee including redness,
             warmth and or a large bulging effusion with the loss of normal contour

          -  Crystalline-induced synovitis in the index knee

          -  History, physical examination or radiographic suggestive of acute inflammatory
             arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout,
             pseudogout, fibromyalgia, lupus erythematosus, or other types of inflammatory
             arthritis of the index knee
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