Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients
试验速览
- 阶段
- 3 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 patients with healing of erosive esophagitis(The absence of esophageal lesions)
研究概览
简要总结
The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.
详细描述
This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18~75 years
- •Patients whose esophageal lesions graded over LA A grade (The severity of lesions is classified by LA classification)
- •Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation during the past 3 month
- •Symptoms on at least 2 days of the past 7 days
排除标准
- •PPI treatment within 4 weeks before dosing or treatment of H2 blocker, sucralfate, prokinase NSAID (except low dose aspirin) within 2 weeks before dosing.
- •Patients whose history of GI tract resection or vagotomy.
- •Barrett's oesophagus greater than 3cm in length and high-grade dysplasia.
- •Acid irrelevant Heartburn and regurgitation.
- •Zollinger Ellison syndrome
- •Hypersensitive and/or allergy to Pantoprazole and/or other PPI
- •Pregnancy and lactation
- •peptic ulcer
- •serious hepatic
- •any other renal, cardiac or haematological disease.
- •Patients participated any other clinical studies during the past 3 months.
研究组 & 干预措施
S-Pantoprazole
Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole)
干预措施: AGSPT201 Tab contains S-pantoprazole (Drug)
结局指标
主要结局
Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)
时间窗: 4 week
Endoscopy is performed at baseline and 4 week. All patients whose esophageal lesions are graded (LA Grade A, B, C and D). The study is completed for the patients whose esophageal lesions are healed. However patients whose esophageal lesions are not healed at 4 week were treated for an additional 4 week with endoscopy repeated at 8 week. At 8 week, the study is completed regardless healing of esophageal lesions.
次要结局
- Absence and/or improvement of typical reflux symptoms(4 week)