NCT05267743已完成4 期
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease
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
- 218
- 试验地点
- 1
- 主要终点
- 4 weeks cumulative ERD healing rate(%)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.
详细描述
This is a double blind, radomized, active-controlled, phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (Tegoprazan 50mg, Lansoprazole 30mg)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Erosive eshophagitis(LA calssfication Grades A to D) with in 30 days prior to Randomization
- •Those who have experienced heartburn symptoms within 7 days prior to Visit 1(screening date)
排除标准
- •Unalbe to undergo upper GI endoscopy
- •H. pylori positive
- •Those who cannot write a clinical trial subject diary
- •Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3cm length(LSBE), eosinophilic oesophagitis, active digestive ulcer or gastric bleeding on an upper GI endoscopy
研究组 & 干预措施
Tegoprazan 50mg QD
Experimental
Tegoprazan 50mg tablet, once daily, oral administration
干预措施: Tegoprazan 50mg QD (Drug)
Lansoprazole 30mg QD
Active Comparator
Lansoprazole 30mg capsule, once dauly, oral administration
干预措施: Lansoprazole 30mg QD (Drug)
结局指标
主要结局
4 weeks cumulative ERD healing rate(%)
时间窗: 4 weeks
Healing is defined as "not present" erosions or fissures according to the LA classification.
次要结局
- 2 weeks ERD healing rate(%)(2 weeks)
- Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type(2 weeks or 4 weeks)
- Percentage of days without heartburn through the clinical trial subject dairy (%)(2 weeks or 4 weeks)
- RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity)(2 weeks or 4 weeks)
- Incidence of Adverse Events [Safety](2 weeks or 4 weeks)
研究者
研究点 (1)
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