KCT0000629招募中未知
For 12weeks, the Multi-center, Randomized, Double-blinded, Clinical study to evaluate the Efficacy and Safety of Entelon®150mg tablet compared with Celebrex capsule in patients with Osteoarthritis of knee(Phase III).
Hanlim Pharmaceutical0 个研究点目标入组 336 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 35(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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