NCT02028663已完成2 期
A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Cumulative healing rate of erosive esophagitis at 8-week
研究概览
简要总结
The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 20-70
- •Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment
排除标准
- •Patients who cannot undergo EGD
- •Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
- •Patients who took PPIs within 2 weeks prior to study drug administration
- •Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
- •Clinically significant abnormal laboratory values during screening
研究组 & 干预措施
CJ-12420 Amg
Experimental
50 volunteers will be administered CJ-12420 Amg
干预措施: CJ-12420 (Drug)
CJ-12420 Bmg
Experimental
50 volunteers will be administered CJ-12420 Bmg
干预措施: CJ-12420 (Drug)
CJ-12420 Cmg
Experimental
50 volunteers will be administered CJ-12420 Cmg
干预措施: CJ-12420 (Drug)
Esomeprazole 40mg
Active Comparator
50 volunteers will be administered Esomeprazole 40mg
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Cumulative healing rate of erosive esophagitis at 8-week
时间窗: 8 week
次要结局
- Healing rate of erosive esophagitis at 4-week(4 week)
研究者
研究点 (1)
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