Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
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ClinicalTrials.gov Identifier: NCT01768520
Verified January 2013 by Hanlim Pharm. Co., Ltd.. Recruitment status was: Recruiting
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.
Condition or disease
Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeksDrug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeksDrug: Placebo
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)
Study Start Date
Estimated Primary Completion Date
Estimated Study Completion Date
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Ages Eligible for Study:
35 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
more than one case among
50 years or over
morning stiffness less than 30 min
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
patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1