NCT02651714已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
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
- 168
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.
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 and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive)
- •Diagnosed with atopic dermatitis
- •Suffering from chronic pruritus with pruritus being actively present
排除标准
- •Chronic pruritus due to condition other than atopic dermatitis (AD)
- •Participation in a previous tradipitant (LY686017 or VLY-686) trial
- •Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
- •Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results
研究组 & 干预措施
Tradipitant
Experimental
Oral
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
Oral
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score
时间窗: 56 days
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).
次要结局
未报告次要终点
研究者
研究点 (1)
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