NCT07160790尚未招募3 期
Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux(NERD) Disease: Double-blind, Randomized
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 321
- 主要终点
- The proportion of days with no heartburn
研究概览
简要总结
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have experienced both heartburn and acid regurgitation
- •Subjects in whom no mucosal breaks were observed on upper GI endoscopy at Visit 1 by LA Classification
- •Subjects who fully understand this clinical trial and voluntarily signed the informed consent form
排除标准
- •Subjects who have significant gastrointestinal diseases or procedures affecting the esophagus, stomach, or duodenum
- •Subjects who have a history of recent substance abuse, malignancy, systemic autoimmune or immune deficiency diseases, refractory response to PPI/P-CAB, hypersensitivity to study drugs, genetic metabolic disorders, or significant psychiatric conditions.
- •Subjects who showed clinically significant abnormalities in laboratory tests
- •Positive result in the H. pylori test
- •Pregnant or breast-feeding women
- •Subjects who require hospitalization are scheduled to undergo surgery during the study period, or have undergone major surgery requiring general anesthesia
- •Other people deemed unsuitable for participation in this study according to the medical opinion of the investigator
研究组 & 干预措施
Group 1: JP-1366 A mg + Placebo
Experimental
干预措施: JP-1366 + placebo (Drug)
Group 2: JP-1366 B mg + Placebo
Experimental
干预措施: JP-1366 + placebo (Drug)
Placebo + Placebo
Placebo Comparator
干预措施: Placebo + Placebo (Drug)
结局指标
主要结局
The proportion of days with no heartburn
时间窗: The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks
次要结局
未报告次要终点
研究者
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