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

Phase 3

Completed

Conditions: Knee Osteoarthritis

Interventions: Drug: Placebo

Registration Number: NCT01768520

Lead Sponsor: Hanlim Pharm. Co., Ltd.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 338

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.
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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)	baseline and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
the Change of Numeric Rating Scale	baseline and 12 weeks	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.