Randomized, Double-blind, Active-controlled, Multi-center Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
This study is to investigate the optimal clinical dose and administration methods of YH4808 in patients with reflux esophagitis by evaluating the safety and efficacy after YH4808 oral administration.
详细描述
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History or presence of upper gastrointestinal anatomic or motor disorders
- •Other exclusions apply.
研究组 & 干预措施
YH4808 A mg (Twice daily)
YH4808 A mg (Twice daily, Oral administration)
干预措施: YH4808 A mg (Drug)
YH4808 B mg (Once daily)
YH4808 B mg (Once daily, Oral administration)
干预措施: YH4808 B mg (Drug)
YH4808 B mg (Twice daily)
YH4808 B mg (Twice daily, Oral administration)
干预措施: YH4808 B mg (Drug)
YH4808 C mg (Once daily)
YH4808 C mg (Once daily, Oral administration)
干预措施: YH4808 C mg (Drug)
Esomeprazole 40mg (Once daily)
Esomeprazole 40mg (Once daily, Oral administration)
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
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
时间窗: Week 4
次要结局
- Nocturnal Symptom Free Days & Symptom Free Days(Treatment Period)
- Symptom Score(Treatment Period)
- 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(Week 8)
- Global Impression of Change (Patient, Investigator)(Check at 4, and 8 weeks.)
- Sustained resolution of symptom & Time to first sustained symptom resolution(Treatment Period)
- Serum Gastrin Level(Check at Baseline(Pre-dose), 2, 4, and 8 weeks.)
- Quality of Life(Check at Baseline(Pre-dose), 4, and 8 weeks.)
- Epworth Sleepiness Scale(Check at Baseline(Pre-dose), 2, 4, and 8 weeks.)