A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change From Baseline in Average Nausea Severity
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. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.
The study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind 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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosed with gastroparesis;
- •Subjects must agree to the use of contraception
- •Ability and acceptance to provide written informed consent;
- •Willing to participate in the pharmacogenomics sample collection;
- •Willing and able to comply with all study requirements and restrictions
- •Willing to not participate in any other interventional trial for the duration of their participation.
排除标准
- •Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);
- •Pregnancy or nursing;
- •History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
- •Use of another NK1 antagonist or palonosetron;
- •Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
- •Any other reason as determined by the Investigator 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
Study Drug
VLY-686 (Tradipitant) oral capsule for 4 weeks.
干预措施: VLY-686 (Tradipitant) (Drug)
Placebo
Placebo oral capsule for 4 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Average Nausea Severity
时间窗: 4 weeks
The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.
次要结局
- PAGI-SYM, Change From Baseline(4 weeks)
- Daily Average Vomiting Frequency, Change From Baseline(4 weeks)
- Weekly % Nausea-Free Days(4 weeks)
- CGI-S, Change From Baseline(4 weeks)
- Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline(4 weeks)
- PGI-C(4 weeks)