NCT04028492已完成3 期
VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 992
- 试验地点
- 1
- 主要终点
- Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
研究概览
简要总结
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with gastroparesis
- •Demonstrated delayed gastric emptying
- •Presence of moderate to severe nausea
- •Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
排除标准
- •Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
- •A positive test for drugs of abuse at the screening or evaluation visits;
- •Exposure to any investigational medication in the past 60 days
- •Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
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)
Open Label Tradipitant
Experimental
Oral Capsule
干预措施: Open Label Tradipitant (Drug)
结局指标
主要结局
Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
时间窗: 12 weeks
A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).
次要结局
- Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary(12 weeks)
- Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)(12 weeks)
- Change from baseline in Patient Global Impression - Change (PGI-C)(12 weeks)
- Clinician Global Impression - Severity (CGI-S)(12 weeks)
- Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)(12 weeks)
研究者
研究点 (1)
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