NCT04309916已完成4 期
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Time to first nighttime heartburn-free interval (days))
研究概览
简要总结
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
详细描述
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged between 19 and 75 years
- •Subjects who have erosive reflux disease
排除标准
- •Unable to undergo upper GI endoscopy
- •Symptoms of primary or secondary esophageal movement disorders
- •Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)
研究组 & 干预措施
Tegoprazan 50mg
Experimental
Tegoprazan 50mg tablet, once daily, oral administration
干预措施: Tegoprazan (Drug)
Esomeprazole 40mg
Active Comparator
Esomeprazole 40mg tablet, once daily, oral administration
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Time to first nighttime heartburn-free interval (days))
时间窗: 2 week
Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.
次要结局
- Percentage of days without nighttime heartburn during the 2-week dosing period(2 week)
研究者
研究点 (1)
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