Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee

Inclusion criteria

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

• knee arthralgia
• more than one case among

• 50 years or over

• morning stiffness less than 30 min

• friction sound
• osteophyte in radiography
• Kellgren and Lawrence Scale Grade II~III
• total sum of K-WOMAC Scale more than 30
• negative results in pregnancy test of urine in screening period
• if women in childbearing age, medically reliable contraception or menopause
• patients who give written consent of agreement to voluntarily participate in the clinical study
• patients who can read and understand written instructions

Exclusion criteria

• patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1
• fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout
• knee OA with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary osteochondromatosis
• anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint
• wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation
• patients with administration of injectable hyaluronic acid to the target joint within 6 months prior to study participation
• severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular disease, congestive heart failure, active bronchial asthma
• medical history of malignant tumor
• active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease
• hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide derivatives or vitis vinifera or intolerance with fructose, glucose or galactose
• continuously(1 week or more) oral or intraarticular administration of corticosteroids within 12 weeks prior to study participation
• pregnant or lactating women
• patients who have experience to participate in other clinical trial within 4 weeks prior to study participation
• ALT, AST and Serum Creatinine ≥ 2×UNL
• drug administration after diagnosing as alcoholic or psychical disease
• patients whom the investigators judge as improper to participate in this clinical trial