NCT01756937已完成4 期
A Six-month, Multi Center, Randomizied, Double Blind, Parallel-group,Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 9
- 主要终点
- Change from baseline in the Lequesne's index score at 24weeks
研究概览
简要总结
Efficacy and safety of Imotun capsule in osteoarthritis of the knee
详细描述
A six-month, multi center, randomizied, double blind, parallel-group,placebo controlled study to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreement with written informed consent and 40 years of age and older
- •Patients with more than 63months history of OA of knee according to ACR criteria
- •Radiographic evidence of Kellgren & Lawrence grade II to III OA of the knee
- •The 100mm Pain VAS is over 40mm
- •The Lequensne's index is over 5
排除标准
- •Treatment with SYSADOA within 3 months
- •History of joint surgery within 5 years or Arthroscopic surgery within 1year
- •Intra-articular injections within 3 months
- •Treatment with NASIDs within 7 days
- •Any history of adverse reaction to the study drugs
- •clinically significant hepatic, renal, cardiovascular diseases
- •Patients with gastrointestinal ulcers or bleeding disorders
- •Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
- •History of drug abuse or alcoholism
- •Patients on any other clinical trial or experimental treatment in the past 4 weeks
- •An impossible one who participates in clinical trial by investigator's decision
研究组 & 干预措施
Imotun
Active Comparator
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
干预措施: Imotun (Drug)
Placebo
Placebo Comparator
1 capsule once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the Lequesne's index score at 24weeks
时间窗: baseline, 24 weeks
Change from baseline in the Lequesne's index score at 24weekS
100mm Pain VAS
时间窗: 24 weeks
assessment of 100mm Pain VAS (24weekS)
次要结局
- Change from baseline Lequesne's index score at 4weeks(baseline, 4 weeks)
- dosing quantity of the rescue medication(24weeks)
- Global assement (Patient, Physician)(24weeks)
- change from baseline 100mm Pain VAS at 8weeeks(baseline, 8weeks)
- Change from baseline Lequesne's index score at 8weeks(baseline, 8 weeks)
- Change from baseline Lequesne's index score at 16weeks(baseline, 16 weeks)
- The rate of patients who consumed the rescue medication(24weeks)
- 100mm Pain VAS(16weeks)
- change from baseline 100mm Pain VAS at 24weeeks(baseline, 24 weeks)
- change from baseline Global assement (Patient, Physician)(baseline, 16weeks)
- administration days of the rescue medication(24weeks)
- change from baseline 100mm Pain VAS at 4weeeks(baseline, 4weeks)
- change from baseline 100mm Pain VAS at 16weeeks(baseline, 16 weeks)
研究者
研究点 (9)
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