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

Study Overview
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Brief Summary
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This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.

Official Title
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For 12 Weeks, the Multi-center, Randomized, Double-blinded, Clinical Study to Evaluate the Efficacy and Safety of Entelon Tab. 150mg Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee (Phase III)

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks
* Drug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entelon tab. 150mg<br> | Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks<br>* morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex evening : 1 tab. of active Entelon 150mg<br>|
| Active Comparator: Celebrex cap.<br> | Drug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks<br>* morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex evening : 1 tab. of placebo Entelon 150mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex evening : 1 tab. of placebo Entelon 150mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index) | Range of total K-WOMAC score: 0-96 K-WOMAC consists of evaluations of pain, stiffness, physical function. The total K-WOMAC score is the sum of all subscale scores. Higher scores mean a worse outcome. Range of Subscale K-WOMAC score: pain(0-20), stiffness(0-8), physical function(0 68) Higher scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Change of Numeric Rating Scale | Numeric Rating Scale is 10 point scale(0 10 score). 0 score: no pain, 10 score: worst possible pain If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. | baseline and 12 weeks |