Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks; Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks; Placebo
Intervention description: morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex
evening : 1 tab. of active Entelon 150mg; morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex
evening : 1 tab. of placebo Entelon 150mg; morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex
evening : 1 tab. of placebo Entelon 150mg
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 338.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

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