Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis
Randomized, Double-blind, Active-controlled, Multi-center Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis
研究概览
详细说明
In the result of recent meta-analysis, there was no improvement in symptoms with the first administration of PPI in about 75% of GERD patients, and symptoms were still sustained in about 50% of patients after administration of more than 3 days. Especially the nocturnal secretion of gastric acid was not effectively inhibited, and about 25% of GERD patients could not achieve the proper therapeutic effects even after PPI treatment twice daily for 4-8 weeks.
YH4808, as a selective K+- competitive acid blocker (P-CAB), is no need for activation by gastric acid since it competitively inhibits proton pump with K+. Thus, the inhibition of gastric acid secretion by YH4808 is prompt and effective. In addition, the inhibitive effect of gastric acid secretion by stimulation of histamine is proved to be more powerful than PPI (esomeprazole) and sustained in in-vitro/in-vivo model, and 24-h inhibition of gastric acid secretion and especially nocturnal inhibition of gastric acid secretion was observed to be superior to esomeprazole with repeat doses for 7 days in healthy volunteers.
Based on these nonclinical and clinical outcomes, an exploratory phase-II clinical trial is to be conducted to determine the proper treatment dose and administration method of YH48084 for GERD patients.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Seoul、大韩民国、137-701
- Seoul St.Mary's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject who has signed on the written consent
- Male and female aged 20 and over
- Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 2 weeks before randomisation
Exclusion Criteria:
- History or presence of upper gastrointestinal anatomic or motor disorders
- Other exclusions apply.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：YH4808 A mg (Twice daily)
YH4808 A mg (Twice daily, Oral administration)
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1 tablet = YH4808 A mg
其他名称：
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实验性的：YH4808 B mg (Once daily)
YH4808 B mg (Once daily, Oral administration)
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1 tablet = YH4808 B mg
其他名称：
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实验性的：YH4808 B mg (Twice daily)
YH4808 B mg (Twice daily, Oral administration)
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1 tablet = YH4808 B mg
其他名称：
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实验性的：YH4808 C mg (Once daily)
YH4808 C mg (Once daily, Oral administration)
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YH4808 C mg = 2 x YH4808 B mg
其他名称：
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有源比较器：Esomeprazole 40mg (Once daily)
Esomeprazole 40mg (Once daily, Oral administration)
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1 tablet = Esomeprazole 40 mg
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of Participants With Healing of Reflux Esophagitis (RE) Who Were "Normal(including minimal change)" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification
大体时间：Week 4
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Week 4
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of Participants With Healing of Reflux Esophagitis (RE) Who Were "Normal(including minimal change)" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification
大体时间：Week 8
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Week 8
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Nocturnal Symptom Free Days & Symptom Free Days
大体时间：Treatment Period
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Treatment Period
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Sustained resolution of symptom & Time to first sustained symptom resolution
大体时间：Treatment Period
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Treatment Period
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Symptom Score
大体时间：Treatment Period
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Treatment Period
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Serum Gastrin Level
大体时间：Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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Global Impression of Change (Patient, Investigator)
大体时间：Check at 4, and 8 weeks.
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Check at 4, and 8 weeks.
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Quality of Life
大体时间：Check at Baseline(Pre-dose), 4, and 8 weeks.
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Check at Baseline(Pre-dose), 4, and 8 weeks.
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Epworth Sleepiness Scale
大体时间：Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Nocturnal Symptom Free Days & Symptom Free Days
大体时间：Follow-up period
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Follow-up period
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Sustained resolution of symptom
大体时间：Follow-up period
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Follow-up period
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Symptom Score
大体时间：Follow-up period
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Follow-up period
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Healing Rate of Reflux Esophagitis by Baseline According to Los Angeles Classification(LA Grade A~D Subgroup Analysis)
大体时间：Check at Baseline, Week 4 and Week 8
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Check at Baseline, Week 4 and Week 8
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Healing Rate of Reflux Esophagitis and Symptom related endpoints by H.pylori positive or negative
大体时间：Treatement & Follow-up period
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Treatement & Follow-up period
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Adverse events, Physical examination results, ECG, Vital sign, Lab results
大体时间：Treatment & Follow-up period
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Treatment & Follow-up period
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合作者和调查者
调查人员
- 首席研究员：Myung Gyy Choi, M.D., Ph.D.、Catholic Univ. Seoul St. Mary Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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