Clinical trial: Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients (NCT01576419)

Eligibility criteria:
Inclusion Criteria:

          1. Patients ≥40 and ≤ 80years of age.

          2. Patients who meet the American College of Rheumatology clinical plus radiographic
             classification criteria for idiopathic osteoarthritis of the knee, which are defined
             as follow:

             a patient who had knee pain and radiographically diagnosed osteophytes and met at
             least one of the followings.

               -  Age> 50 years.

               -  Morning stiffness for less than 30 minutes.

               -  Crepitus during movement of the weight-bearing knee.

          3. Patients with symptomatic primary osteoarthritis of the knee at least in the last 3
             months prior to screening.

          4. Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2
             inhibitor for the treatment of arthritis of the knee for at least 5 days a week during
             4 weeks prior to screening.

          5. Patients who had a score of 100mm pain VAS ≤80 mm at screening.

          6. Patients who had a score of 100mm pain VAS ≥50 mm at baseline.

          7. Patients should be able and willing to provide the written informed consent.

        Exclusion Criteria:

          1. Patients with a history of surgery or arthroscopy of the study joint within the
             previous 6 months.

          2. Patients with trauma of study joint within the previous 12 months.

          3. Patients with symptomatic hip osteoarthritis, other condition that would interfere
             with study assessments.

          4. Patients with any other type of arthritis, active malignancies or any active GI,
             cardiovascular, renal, hepatic, neurologic, or psychiatric disease.

          5. Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory
             drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.

          6. Patients with uncontrollable hypertension.

          7. Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate
             aminotransferase > 1.5 times the Upper Lange of normal at screening.

          8. Patients with a history of drug or alcohol abuse.
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 80 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? Entailment