Clinical trial: Flavocoxid, A Plant-Derived Therapy, for the Treatment of Knee Osteoarthritis (NCT00294125)

Eligibility criteria:
Inclusion Criteria:

          -  Meet American College of Rheumatology (ACR) clinical criteria for knee OA

          -  In good medical and psychological health

          -  Able and willing to discontinue NSAIDs, natural therapies, and other pain medications
             for OA for 1 week prior to the first study visit and also throughout the course of the
             clinical trial

          -  Knee pain rated greater than 4 cm on a 10 cm visual analog scale (VAS)

          -  Intends to stay in the area and complete the 12-week protocol

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria:

          -  Serious or unstable concomitant medical or psychological illnesses that would impair
             the patient's ability to complete the study

          -  Significant cardiac disease OR history of myocardial infarction in the 12 months prior
             to study entry

          -  Uncontrolled hypertension

          -  Significant bleeding disorders. Participants who have bleeding disorders related to
             uncontrolled, bleeding hemorrhoids occurring in the 12 months prior to study entry are
             not excluded.

          -  Uncontrolled gastrointestinal disease resulting in bleeding in the 60 days prior to
             study entry. Participants with controlled and uncomplicated ulcers are not excluded.

          -  Inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain
             syndrome

          -  Severe pes anserine bursitis, acute joint trauma, or complete loss of articular
             cartilage on the index knee

          -  Intravenous, intramuscular, or intra-articular steroids to the index joint within 60
             days of study screening

          -  Alcohol, intravenous drug, or prescription drug abuse

          -  Investigational drugs within 30 days of study screening

          -  Current use of anticoagulants such as warfarin

          -  Oral corticosteroids or other immunosuppressants within 6 months of study screening

          -  Severe psoriasis requiring use of biologic immunomodulators such as alefacept,
             etanercept, infliximab, or cyclosporine

          -  Hypersensitivity to analgesics, cyclo-oxygenase inhibitors, lipoxygenase inhibitors,
             or flavonoids

          -  Pregnancy or breastfeeding

        Exclusion Criteria Postenrollment:

          -  Abnormal laboratory test results at study screening, as determined by the investigator

          -  Liver enzyme levels (SGOT, SGPT, alkaline phsphatase) two times the upper limit of
             normal

          -  Leukocyte counts less than 3.5 times 109/L or platelet counts less than 150 times
             109/L

          -  At increased risk for cardiovascular problems based on the Framingham Cardiac Risk
             assessment questionnaire

          -  Kellgren/Lawrence radiographic score of 0, 1, or 4 on x-ray of index joint taken
             within 12 months of study entry

          -  Impaired renal function (creatinine greater than 1.5 mg/dl)
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 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? 1