A Double Blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Cumulative healing rate of gastric ulcer at 8-week
研究概览
简要总结
To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.
详细描述
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).
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
- •Diagnosis of 1 or more active gastric ulcers (≥3 mm ~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.
排除标准
- •Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of >3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
- •Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
- •Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
- •Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
- •Subjects who participated in the other clinical trial within 4 weeks prior to randomization
研究组 & 干预措施
CJ-12420 50 mg QD
CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks
干预措施: CJ-12420 50 mg QD (Drug)
CJ-12420 100 mg QD
CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks
干预措施: CJ-12420 100 mg QD (Drug)
Lansoprazole 30 mg QD
Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks
干预措施: Lansoprazole 30 mg QD (Drug)
结局指标
主要结局
Cumulative healing rate of gastric ulcer at 8-week
时间窗: 8 weeks
次要结局
- Healing rate of gastric ulcer at 4-week(4 weeks)
- Week 8 healing rates by H. pylori infection(8 weeks)