KCT0000732已完成未知
A 12 week, multi-center, randomized, double-blind, placebo-controlled, parallel, phase II trial to evaluate the efficacy and safety of WIN-34B in patients with Osteoarthritis of the knee
Hamsoa Pharmaceutical0 个研究点目标入组 150 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
- 150
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
- 35(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Being between 35 and 80 years of age
- •2) Diagnosised with Osteoarthritis of the knee at least 3 months
- •3) Diagnosised with Osteoarthritis of the knee, based on ACR criteria
- •4) Able to communicate with researchers and write questionnaire
- •5) At the screening visit, checking 100mm Pain VAS at least 80mm
- •6) At randomization(Visit 2), checking 100mm Pain VAS over 50mm
- •7) Agreeing to participate and signing informed consent voluntarily
排除标准
- •1) Previous intra-articular injection on knee within 3 months
- •2) Previous knee surgery within 6 months or scheduled procedures
- •3) Other diseases that could affect or interfere with the therapeutic outcomes
- •4) Experiencing habitual use of psychotropic, narcotic analgesic drugs over 1 week
- •5) Diagnosised with gastrointestinal diseases, unable to stop medicines during the study
- •6) At the screening visit, identified liver dysfunction
- •7) At the screening visit, identified renal dysfunction
- •8) Patients who cannot take NSAIDs
- •9) Pregnancy and breast-feeding (women of childbearing age need pregnancy test)
- •10) Physicological or mental disorders, including drug-takers
- •11) Orthopedic diseases that could affect or interfere with the therapeutic outcomes
- •12) Inappropriate for the study
研究者
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