NCT01768520已完成3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •knee arthralgia
- •more than one case among
- •50 years or over
- •morning stiffness less than 30 min
- •friction sound
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)
时间窗: 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.
次要结局
- the Change of Numeric Rating Scale(baseline and 12 weeks)
研究者
研究点 (1)
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