Clinical trial: Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee (NCT02554240)

Eligibility criteria:
Inclusion Criteria:

          -  male and female patients between 20 and 80 y old

          -  primary knee osteoarthritis confirmed clinically and radiologically according to
             American College of Rheumatology criteria and have following 3 items

               1. knee joint pain

               2. have any of the following

                    1. males and females more than 50 y

                    2. morning stiffness within 30 minutes

                    3. crepitus

               3. presence of spur on radiological evidence

          -  Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically

          -  knee pain under weight-bearing greater than 40/100mm-VAS(Visual Analogue Scale) at
             randomization visit

          -  patients willing and able to provide signed informed consent after the nature of the
             study has been explained

        Exclusion Criteria:

          -  BMI(Body Mass Index) > 32

          -  complete obliteration of femoropatellar joint space on X-ray

          -  Kellgren-Lawrence Grade IV

          -  knee surgery within a year

          -  history of fracture, rheumatoid arthritis or other inflammatory arthritis in knee
             articular cavity

          -  intra-articular corticosteroid injection within 3 months or hyaluronate injection
             within 6 months

          -  skin diseases or infection overlying the joint

          -  history of severe drug allergy or hypersensitivity to drugs(piroxicam, hyaluronic
             acid)

          -  history of allergy, asthma, rhinitis, angioedema, rash to aspirin or other NSAIDs
             (including COX-2 inhibitor)

          -  treatment with anticoagulants such as heparin or coumarins (warfarin etc.)

          -  History of GI diseases such as peptic ulcer, bleeding, perforation, ulcerative
             colitis, Crohn's disease within 1 year

          -  severe hypertension

          -  patients with psychiatric disorder, alcoholism, drug addiction

          -  presence of severe concomitant diseases or malignancy within 5 years

          -  have participated in another clinical trial 4 weeks prior to the study

          -  women of child-bearing potential who are not using *adequate means of contraception
             (*adequate means of contraception: condom, oral contraception, barrier methods using
             spermicide, intrauterine devices etc.)

          -  any condition that, in the view of the investigator, would interfere with study
             participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 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? 1