Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Severity of Pruritus
研究概览
简要总结
The purpose of this randomized, double-blinded, placebo-controlled study is to test the hypothesis that administration of aprepitant will decrease the severity of pruritus in patients with Sèzary Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known Sezary Syndrome
- •Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale >
- •Age 18 through 80 years of age.
- •Stable medication regimens for both Sezary Syndrome and pruritus for 3 months prior to study participation.
排除标准
- •Known hepatic impairment (defined as liver function tests >3 times the upper limit of normal).
- •Pregnancy (all women of child-bearing potential will undergo urine beta-hcg testing).
- •Concurrent use of pimozide, terfenadine, astemizole, or cisapride.
研究组 & 干预措施
Aprepitant
Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.
干预措施: Aprepitant (Drug)
Placebo
Matching placebo will be given in place of aprepitant
干预措施: Placebo (Drug)
结局指标
主要结局
Severity of Pruritus
时间窗: one week
The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.
次要结局
- Quality of Life(one week)
研究者
Nancy J. Brown
Chair and Physician-in-chief, Department of Medicine, Hugh Jackson Morgan Professor Medicine and Pharmacology, Vanderbilt University School of Medicine
Vanderbilt University