A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- 1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week
研究概览
简要总结
The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.
详细描述
This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).
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
- •Subjects aged between 20 and 75 years
- •Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD
- •Subjects who had experienced major symptom within 3 months
- •Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week
- •Subjects who is able to understand and follow the instructions
- •Subjects who voluntarily signed written informed consent form
排除标准
- •Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy
- •Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1
- •Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months
- •Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery
- •Subjects with Zollinger-Ellison syndrome
- •Subjects with eosinophilic esophagitis
- •Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease .
研究组 & 干预措施
DWP14012 A mg
DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks
干预措施: DWP14012 A mg (Drug)
DWP14012 B mg
DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks
干预措施: DWP14012 B mg (Drug)
Placebo
Placebo, tablet, once daily, oral administration for up to 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week
时间窗: 4 week
defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)
次要结局
- Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)(2 week, 4 week)
- Quality of Life assessment using PAGI-QoL(4 week)
- Reflux disease symptom assessment using Subject diary(4 week)
- Use of rescue medication(4 week)