NCT03218501已完成2 期
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 1
- 主要终点
- Change from baseline in Worst-itching Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving hemodialysis three times a week for at least 12 weeks
- •Worst itching VAS in a day is 30 mm or more at least 5 days during the first observation period
- •Mean worst itching VAS is 50 mm or more in both the first and second observation periods
排除标准
- •Complications that may affect the assessment of uremic pruritus
- •Started or changed pruritus treatment within 13 days prior to starting observations
- •Received ultraviolet treatment within 27 days prior to starting observations
- •Uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor
- •Depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism
- •Pregnancy, or breastfeeding
研究组 & 干预措施
SK-1405 high dose
Active Comparator
SK-1405 high dose is to be administered orally once daily for 2 weeks
干预措施: SK-1405 high dose (Drug)
SK-1405 low dose
Active Comparator
SK-1405 low dose is to be administered orally once daily for 2 weeks
干预措施: SK-1405 low dose (Drug)
Placebo
Placebo Comparator
Placebo is to be administered orally once daily for 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Worst-itching Visual Analog Scale (VAS)
时间窗: 2 weeks
次要结局
- Change from baseline in 5D Itch Scale(2 weeks)
- Number of Participants with Adverse Events(5 weeks)
- Change from baseline in Sleep Quality Assessment(1 week, 2 weeks, 3 weeks)
- Change from baseline in Worst-itching Visual Analog Scale (VAS)(1 week, 3 weeks)
- Change from baseline in Itch Severity Assessment(1 week, 2 weeks, 3 weeks)
研究者
研究点 (1)
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