NCT01743287已完成4 期
A Six-month, Multi Center, Randomized, 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
- 234
- 试验地点
- 10
- 主要终点
- 100mm pain VAS
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee
详细描述
This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.
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
- •Female and male patients who aged 40 or more and agreement with written informed consent
- •Patients with osteoarthritis according to ACR criteria lasted for the past 3 months or more
- •Patients with Kellgren & Lawrence grade Ⅱ~Ⅲ on radiographs
- •Patients with 40mm or higher 100mm Pain VAS on screening and baseline visit (based on more painful knee)
- •Patients with Lequesne's index 5 or more on screening and baseline visit
排除标准
- •Patients who had taken SYSADOA within the past 3 months (Imotun, diacerein, s-adenosyl-methionone, JOINS, glucosamine, chondroitin and any other cartilage protective agents determined by investigator)
- •Patients who experienced cartilage surgery within the past 5 years or arthroscope surgery within a year(one side or both)
- •Patients who were treated with joint space injection within the past 3 months
- •Patients who had taken NSAIDs including pain killers within 7 days (except, it is acceptable to enroll the study if the patients have wash out periods at least 7 days before randomization)
- •Patients with hypersensitivity or allergy to the study or rescue medicine or those who have medical history.
- •Patients with severe liver, kidney or cardiac diseases who are not acceptable for the study determined by investigator
- •Patients with active peptic ulcer or GI bleeding.
- •Pregnancy, nursing women or women of reproductive age who do not agree to the contraception.
- •Patients with abuse of alcohol, illegal drugs or drug dependency
- •Patients who were treated with another investigational product within the past 4 weeks
- •All other patients who are not acceptable for the study determined by investigator
研究组 & 干预措施
Imotun capsule
Experimental
Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks
干预措施: Imotun capsule (Drug)
Imotun capsule placebo
Placebo Comparator
Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks
干预措施: Imotun capsule placebo (Drug)
结局指标
主要结局
100mm pain VAS
时间窗: 24 weeks
assessment of the 100mm pain VAS
change from baseline Lequesne's index score at 24 weeks
时间窗: baseline, 24 weeks
次要结局
- change from baseline Lequesne's index score at 4 weeks(baseline, 4 weeks)
- change from baseline 100mm pain VAS at 4 weeks(baseline, 4 weeks)
- 100mm pain VAS(16 weeks)
- global assessment(24 weeks)
- administration days of the rescue medication(24 weeks)
- The rate of patients who consumed the rescue medication(24 weeks)
- change from baseline Lequesne's index score at 8 weeks(baseline, 8 weeks)
- change from baseline Lequesne's index score at 16 weeks(baseline, 16 weeks)
- change from baseline 100mm pain VAS at 8 weeks(baseline, 8 weeks)
- change from baseline 100mm pain VAS at 16 weeks(baseline, 16 weeks)
- dosing quantity of the rescue medication(24 weeks)
- change from baseline 100mm pain VAS at 24 weeks(baseline, 24 weeks)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Imotun Capsule in Osteoarthritis of the KneeOsteoarthritis of the KneeNCT01756937Chong Kun Dang Pharmaceutical287
Unknown
1 期
Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich PlasmaKnee OsteoarthritisNCT02365142Clinica Universidad de Navarra, Universidad de Navarra38
已完成
1 期
Safety and Efficacy of an Injectable Medical Device to Treat Knee OsteoarthritisKnee OsteoarthritisNCT01365260Moebius Medical Ltd.40
撤回
1 期
Preliminary Safety and Efficacy of XT-150 in Facet Joint OsteoarthritisOsteoarthritis, SpineNCT04841512Xalud Therapeutics, Inc.
已完成
4 期
A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the KneeOsteoarthritis, KneeNCT01183624Johnson & Johnson Consumer and Personal Products Worldwide626