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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 979
- 试验地点
- 37
- 主要终点
- Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population
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
Oral Capsule
干预措施: Tradipitant (Drug)
Placebo
Oral Capsule
干预措施: Placebo (Drug)
Open Label Tradipitant
Oral Capsule
干预措施: Open Label Tradipitant (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population
时间窗: 12 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 biweekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.
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 Gastroparesis Cardinal Symptom Index (GCSI) Total Score Using MMRM Model ITT Population(12 Weeks)
- Change From Baseline to Week 12 in the Biweekly Percentage of Nausea Free Days Using MMRM Model ITT Population(12 Weeks)
- Change From Baseline in Overall Patient Benefit Scale (OPBS) ITT Population(12 Weeks)
- 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)