Comparison of Entelon tab. and Celebrex cap. in patients with knee osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000629
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 336
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.
(a) knee arthralgia
(b) more than one case among
? 50 years or over
? morning stiffness less than 30 min
? friction sound
(c) 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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the change of total sum of K-WOMAC(Korean version of Western Ontario and McMaster University Osteoarthritis Index);adverse events, lab. test(hematologic examination, urine examination), physical examination(including vital signs)
- Secondary Outcome Measures
Name Time Method the change of NRS(Numerical Rating Scale) after drug administration compared to the before status