A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis
试验速览
- 阶段
- 不适用
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- healing rate at week 4
研究概览
简要总结
The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.
详细描述
Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy.
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
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 19 and 75 years old based on the date of written agreement
- •Those who have been diagnosed with erosive esophagitis of LA Grade A-D on the upper gastrointestinal endoscopy
- •Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days
排除标准
- •Those who have undergone gastric acid suppression or gastric, esophageal surgery
- •Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
研究组 & 干预措施
fed state group
just after a meal
干预措施: DWP14012 (Drug)
fasted state group
before a meal
干预措施: DWP14012 (Drug)
结局指标
主要结局
healing rate at week 4
时间窗: up to 4 weeks
Cumulative healing rate of erosive esophagitis at week 4 by endoscopy
次要结局
未报告次要终点