KCT0008003已完成未知
Clinical study to comparing the pain improvement effects and Safety of injection with Conjuran®(polynucleotide) and hyruan plus® in Patients with Knee Osteoarthritis: Double-blind, Randomized, Single-center, Active-controlled
Seoul Metropolitan Government Seoul National University Boramae Medical Center0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 40(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Adult over 40 years old
- •2)Patient with knee osteoarthritis of grade I-IV according to Kellgren-Lawrence grading scale (K-L grade)
- •3)Patient who has more than one knee having a weight-bearing pain of at least 40mm evaluated by 100mm VAS (the chosen indicator knee joint(targeted knee for this trial) can not change during this trial.)
- •4)Patients expected to be willing to give a written consent and comply with procedures of this clinical trial
排除标准
- •1)Patient with previous traumatic history or trauma which could affect the results of this trial such as fracture of indicator knee joint(targeted knee for this trial)
- •2)Patient with rheumatoid arthritis or other metabolic arthritis
- •3)Patient with inflammation(ex: Osteomyelitis) at indicator knee joint(targeted knee joint for this trial) or around it
- •4)Patient who have joint replacement surgery or procedures in the indicator knee joint(targeted knee joint for this trial)
- •5)Patient who have hip joint osteoarthritis in ipsilateral side of the indicator knee joint(targeted knee joint for this trial)
- •6)Patient with other diseases that may affect the safety and efficacy evaluation of the indicator knee joint (e.g., patients with severe pain, such as complex site pain syndrome, Paget's disease, intervertebral disc prolapse, and gout, recurrent pseudo-gout)
- •7)Patient who received intra-articular hyaluronic acid injections within the previous 6 months of baseline (before study) or those who received intra-joint steroid injections within 3 months or who received oral steroid within a month.
- •8)Patient who needs to take or is taking anticoagulants or platelet aggregation which affect the blood coagulation
- •Injectable anticoagulants: low molecular weight and non-fractional heparin injections, etc.
- •Oral anticoagulants: Warfarin, Dabigatran, Rivaroxaban, etc.
- •Oral antiplatelets: Aspirin, Clopidogrel, Prasugrel, Ticagreleo, etc.
- •[However, if patient take a low dose of aspirin (=300mg/day) for the purpose of treatment and management of cardiovascular disease, registration is possible]
- •9)Patients who have been administered with muscular relaxant, anti-inflammatory drugs(including injection, topical) etc. within 2 weeks from baseline(before study)
- •10)Patient who received physiotherapy (including herbal therapy, thermal therapy, taping therapy, etc.) in the indicator knee joint within two weeks prior to the baseline (before study)
- •11)Patient with hyperactivity to component of investigational device/drug
- •12)Patient with history of dependence of alcohol or drug, or drug abuse
- •13)Patient who is pregnant or lactating
- •14)Childbearing female or male patient who plan to conceive or do not consent to appropriate contraceptive measures* during this clinical trial
- •*oral contraception, implant of hormonal contraception, Intra-uterus device/system(IUD, IUS), double contraception[combination of both condom and gametocide like occlusive cap], surgical sterilization of male etc.
- •15)Patient who had received other investigational device or drug participating in other clinical trial within 3 months before taking part in this clinical trial
- •16)Subject who meets any following exclusion criteria among subjects who completed the wash-out period for 2 weeks from screening test.
- •Administration of prohibited medication or therapy during the period of wash-out
- •Administration of painkillers(including Acetaminophen, Aspirin) within 24 hours from randomization(visit 2)
- •Administration of anesthetic within 48 hours from randomization(visit 2)
- •17)Patient who is judged not to be suitable for this clinical trial due to medical opinion or other reason by investigator
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