A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Endoscopic remission rate of EE at 24-week
研究概览
简要总结
This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.
详细描述
This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
- •Healed erosive esophagitis within 7 days prior to Randomization
- •No heartburn and regurgitation within 7 days prior to Randomization
排除标准
- •Unable to undergo upper GI endoscopy
- •Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
- •Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
- •History of acid-suppressive, esophageal or gastric surgeries
研究组 & 干预措施
Tegoprazan 25mg QD
Tegoprazan 25mg tablet, once daily, oral administration
干预措施: Tegoprazan 25mg QD (Drug)
Lansoprazole 15mg QD
Lansoprazole 15mg capsule, once daily, oral administration
干预措施: Lansoprazole 15mg QD (Drug)
结局指标
主要结局
Endoscopic remission rate of EE at 24-week
时间窗: 24-week
Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)
次要结局
- Endoscopic remission rate of EE at 12-week(12-week)