NCT02975271终止2 期
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 7
- 主要终点
- Change in Itch Intensity - Numeric Rating Scale
研究概览
简要总结
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-65 years at consent.
- •History of serious burn injury
- •Pruritus (itchiness) prior to the initial screening visit and during the screening period
- •Judged to be in good health in the investigator's opinion.
排除标准
- •Prior treatment with study drug or similar drug
- •Pruritus (itchiness) due to another reason besides burn injury/ healing.
- •Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
- •History of hypersensitivity to study drug or any of its components.
- •Currently pregnant or male partner of pregnant female.
- •Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.
研究组 & 干预措施
Serlopitant
Experimental
Dose of experimental drug Serlopitant
干预措施: Serlopitant (Drug)
Placebo
Placebo Comparator
Matching dose of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Itch Intensity - Numeric Rating Scale
时间窗: Week 6
次要结局
- Itch Intensity Responder Rate - Numeric Rating Scale(Week 6)
研究者
研究点 (7)
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