Clinical trial: A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee (NCT00265304)

Eligibility criteria:
Inclusion Criteria:

          -  Patients who completed Study 17-007 or discontinued from Study 17-007 due to lack of
             efficacy

          -  Patients who did not complete or discontinue from Study 17-007 must have
             osteoarthritis of both knees for a minimum of six months

          -  Have moderate pain in the most involved knee when not taking non-steroidal
             anti-inflammatory drugs (NSAIDs)

          -  Must have used an oral NSAID on at least three days per week for the last three
             months, or 25 of the 30 days before screening

          -  Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last
             six months

        Exclusion Criteria:

          -  Any patient currently receiving physical therapy to either knee or having a history of
             allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or
             acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would
             compromise the ability of the subject to complete the required assessments and visits

          -  For patients who did not participate in Study 17-007: having Grade 1 or Grade 4
             severity of the most involved knee based on x-ray criteria

          -  Received intra-articular injections or arthroscopy of the most involved knee during
             three months before screening visit

          -  Have a large bulging effusion, or have inflammation of the most involved knee that
             could be related to gout, pseudogout-induced synovitis, or infection

          -  Have a history of partial or total knee replacement in either knee, or have a history
             of gout, pseudo-gout induced synovitis, or infection of the more severe knee
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Contradiction