A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)
研究概览
简要总结
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease
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
- 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 gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
- •Those who experienced symptoms of heartburn or acid reflux 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
- •Clinically significant abnormal laboratory values during screening
研究组 & 干预措施
Group 3
JP-1366 C mg
干预措施: JP-1366 (Drug)
Group 3
JP-1366 C mg
干预措施: JP-1366 placebo (Drug)
Group 1
JP-1366 A mg
干预措施: JP-1366 (Drug)
Group 1
JP-1366 A mg
干预措施: JP-1366 placebo (Drug)
Group 1
JP-1366 A mg
干预措施: Esomeprazole placebo (Drug)
Group 2
JP-1366 B mg
干预措施: JP-1366 (Drug)
Group 2
JP-1366 B mg
干预措施: JP-1366 placebo (Drug)
Group 2
JP-1366 B mg
干预措施: Esomeprazole placebo (Drug)
Group 3
JP-1366 C mg
干预措施: Esomeprazole placebo (Drug)
Goup 4
Esomeprazole 40 mg
干预措施: JP-1366 placebo (Drug)
Goup 4
Esomeprazole 40 mg
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)
时间窗: 8 weeks
\* Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy
次要结局
未报告次要终点