NCT05653310Enrolling By Invitation2 期
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
Xiao Jing (Iris) Wang2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Accommodation gastric volumes measured by single photon emission computed tomography (SPECT)
研究概览
简要总结
To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written consent
- •Body Mass Index (BMI) of 18-35 kg/m2
- •Absence of other diseases which could interfere with interpretation of study results
排除标准
- •Current H. pylori infection
- •Pregnancy or nursing
- •Recent history of Alcohol Use Disorder or Substance Use Disorder
研究组 & 干预措施
Tradipitant
Experimental
Oral Capsule
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
Oral Capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Accommodation gastric volumes measured by single photon emission computed tomography (SPECT)
时间窗: 4 Weeks
次要结局
未报告次要终点
研究者
Xiao Jing (Iris) Wang
Regulatory Sponsor and Principal Investigator
Mayo Clinic
研究点 (2)
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