Eight-week, Multi-centre, Dose-response, Double Blind, Placebo-controlled, Randomized, Parallel-group, PhaseⅡ Trial to Evaluate Efficacy and Safety of SI000413 in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 入组人数
- 152
- 试验地点
- 3
- 主要终点
- K-WOMAC
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with knee osteoarthritis by orally administration and to determine optimal dose.
详细描述
This is a dose-response, double blind , placebo-controlled study. All patients are required to have 2 weeks washout period from prior medication. Subjects will discontinue current medications 2 weeks prior to randomization. Among those who meet the inclusion criteria, only subjects recording visual analogue scale(VAS) of higher than 40mm(VAS range from 0mm(no pain) to 100mm(unbearable pain)) are enrolled in this study.
Subjects meeting screening criteria will be randomized to receive 8 weeks dosing of an active dose of SI000413 or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females, 35-75 years old
- •Subjects must have a clinical or radiographic diagnosis of primary OA of the knee (diagnosed according to the ACR)
- •The presence of knee pain
- •At least one of the following
- •age older than 50 years
- •morning stiffness lasting less than 30 minutes
- •crepitus with motion
- •Subjects must have been symptomatic for at least 3 months prior to enrollment.
- •Subjects must be required to have experienced a pain intensity of at least 40mm on a 100-mm visual analogue scale in the most severely affected joint during the 24 hours prior to randomization.
- •Adequate liver and kidney function
- •Adequate liver function : SGOT, SGPT must be within 1.5 x normal limit
- •Adequate kidney function : Serum creatinine must be within 1.5 x normal limit
- •Subjects must be able to read, understand and follow the study instructions
- •Subjects must agree to informed consent spontaneously.
排除标准
- •Subjects who are not using adequate birth control.
- •Pregnant or breast-feeding.
- •Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
- •Secondary OA patients
- •Similar OA patients(ex. rheumatic arthritis, bursitis etc)
- •Treatment with intra-articular injections of systemic corticosteroids or hyaluronic acid in the prior 3 months.
- •Use of drugs or psychotropic medicine(methadone maintenance program, codeine, tramadol hydrochloride)
- •Anemia or coagulant disorder
- •Use of anticoagulants or lithium
- •Use of misoprostol or H2-blocker(including anti ulcer medicine)
- •Presence or history of gastrointestinal bleeding within the past 1 year.
- •Subjects who have serious problem with cardiovascular, respiratory, endocrine, central nervous or History of neurotic mental.
- •Active malignancy of any type(ex. lymphoma, multiple myeloma etc)
- •Use of any medication that will affect pain perception during the study period; physical therapy, corticosteroids, NSAIDs, asprin, topical analgesics.
- •Use of glucosamine, chondroitin during the study period.
- •Change of concomitant dose/use within 4 weeks.
- •Known allergy or hypersensitivity to medicine.
- •Subjects received hormone replacement therapy.
- •Use of any other investigational drug within 1 month prior to screening.
- •Investigators determines that it is not appropriate.
研究组 & 干预措施
SI000413 400mg
tablet, SI000413 200mg bid
干预措施: SI000413 (Drug)
SI000413 600mg
tablet, SI000413 200mg tid
干预措施: SI000413 (Drug)
SI000413 800mg
SI000413 200mg, 2T bid
干预措施: SI000413 (Drug)
placebo
placebo 2T tid for 8 weeks
干预措施: microcrystalline cellulose (Drug)
结局指标
主要结局
K-WOMAC
时间窗: Visit 6(8 week), baseline
The primary endpoint will be the change in the sum of the K-WOMAC OA index at Visit 6(8 weeks) vs. baseline(Visit 2, 0 week).
次要结局
- knee pain intensity assessment(baseline, Visit 4(4 week), Visit 6(8 week))
- Global assessment(regarding to disease activity)(Visit 4(4 week), Visit 6(8 week))
- K-WOMAC each domain assessment(baseline, Visit 6(8 week))
- ESR & hs-CRP(baseline, Visit 4(4 week), Visit 6(8 week))