Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee

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