NCT01499368已完成3 期
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Koran Erosive Esophagitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 495
- 主要终点
- Recovery Rates of Reflux Esophagitis
研究概览
简要总结
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
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
- •Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification
排除标准
- •Gastric or duodenal ulcers (excluding ulcer scars)
- •Concurrent presence of Barrett's esophagus
- •A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
- •Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
研究组 & 干预措施
Lafutidine
Experimental
Lafutidine 20mg/day
干预措施: Lafutidine (Drug)
Famotidine
Active Comparator
Famotidine 40mg/day
干预措施: Famotidine (Drug)
Omeprazole
Other
Omeprazole 20mg/day
干预措施: Omeprazole (Drug)
结局指标
主要结局
Recovery Rates of Reflux Esophagitis
时间窗: 8 weeks
Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
次要结局
- The Proportion of Nighttimes Without 'Cardinal Symptom'(4 or 8 week)
- The Proportion of Days Without 'Cardinal Symptom'(4 or 8 week)
- The Proportion of Daytimes Without 'Cardinal Symptom'(4 or 8 week)
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