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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment