Clinical trial: Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee (NCT01768520)

Eligibility criteria:
Inclusion Criteria:

          1. both gender,35 years ≤ age ≤ 75 years

          2. patients with a diagnosis of OA(osteoarthritis) of the knee within 3 months prior to
             study participation, as determined by the American College of Rheumatology clinical
             and radiographic criteria as follows.

               1. knee arthralgia

               2. more than one case among

                    -  50 years or over

                         -  morning stiffness less than 30 min

                              -  friction sound

               3. osteophyte in radiography

          3. Kellgren and Lawrence Scale Grade II~III

          4. total sum of K-WOMAC Scale more than 30

          5. negative results in pregnancy test of urine in screening period

          6. if women in childbearing age, medically reliable contraception or menopause

          7. patients who give written consent of agreement to voluntarily participate in the
             clinical study

          8. patients who can read and understand written instructions

        Exclusion Criteria:

          1. patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1

          2. fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis,
             ankylosing spondylitis, gout or pseudogout

          3. knee OA with secondary causes including major dysplastic or congenital malformation,
             ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary
             osteochondromatosis

          4. anatomical malformation, disease of vertebra or other lower extremities or other
             disease of orthopedics which can disturb the evaluation of the target joint

          5. wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6
             months prior to study participation

          6. patients with administration of injectable hyaluronic acid to the target joint within
             6 months prior to study participation

          7. severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular
             disease, congestive heart failure, active bronchial asthma

          8. medical history of malignant tumor

          9. active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease

         10. hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide
             derivatives or vitis vinifera or intolerance with fructose, glucose or galactose

         11. continuously(1 week or more) oral or intraarticular administration of corticosteroids
             within 12 weeks prior to study participation

         12. pregnant or lactating women

         13. patients who have experience to participate in other clinical trial within 4 weeks
             prior to study participation

         14. ALT, AST and Serum Creatinine ≥ 2×UNL

         15. drug administration after diagnosing as alcoholic or psychical disease

         16. patients whom the investigators judge as improper to participate in this clinical
             trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 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