NCT05701540招募中4 期
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Percentage of days without nighttime heartburn during the 2-week dosing period
研究概览
简要总结
This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
详细描述
This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).
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
- 否
入选标准
- •Subjects aged between 19 and 75 years
- •Subjects who have erosive reflux disease or non-erosive reflux disease
排除标准
- •Unable to undergo upper GI endoscopy
- •Symptoms of primary or secondary esophageal movement disorders
- •Subjects who have undergone or are scheduled to undergo 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, once daily, oral administration for two weeks
干预措施: Tegoprazan (Drug)
Esomeprazole 40mg or 20mg
Active Comparator
- In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks
- In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Percentage of days without nighttime heartburn during the 2-week dosing period
时间窗: 2 weeks
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
次要结局
- Time to first nighttime hearturn-free interval(days)(2 weeks)
- Percentage of days without daytime heartburn during the 2-week dosing period(2 weeks)
研究者
研究点 (1)
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