KCT0001828招募中未知
A double blind, randomized, active-controlled, phase 3 study to evaluate the safety and efficacy of CJ-12420 in patients with erosive esophagitis
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •Subjects aged between 20 and 70 years
- •Subjects who had experienced heartburn and regurgitation within 7 days before visit 1. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week
- •Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within
- •14 days prior to randomization
排除标准
- •Subjects who cannot undergo EGD
- •Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the
- •last 3 months
- •Subjects who took Proton Pump Inhibitor(PPI) within 2 weeks prior to endoscopy
- •Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
- •Subjects with the following clinically significant laboratory abnormalitues:
- •- AST or ALT or ALP or GGT or total bilirubin >2 x Upper Limit Normal (ULN)
- •- BUN or Creatinine >1.5 ULN
研究者
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