A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034 Compared With Rebamipide in Patients With Acute or Chronic Gastritis
试验速览
- 阶段
- 3 期
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).
研究概览
简要总结
This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.
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
- •Diagnosed with acute gastritis or chronic gastritis
- •1 or more erosions found in the gastroscope examination
- •Age should be: 20≤age≤75
排除标准
- •A patient with peptic ulcer and a gastroesophageal reflux disease.
- •Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation
- •Had a surgery regarding gastroesophageal
- •A patient with Zollinger-Ellison syndrome
- •Had a medical history of a malignant tumor
- •A patient who is currently taking anti-thrombotic drugs
研究组 & 干预措施
DA-6034 45mg
two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
干预措施: DA-6034 (Drug)
DA-6034 90mg
two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.
干预措施: DA-6034 (Drug)
Rebamipide 300mg
two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.
干预措施: Rebamipide 300mg (Drug)
结局指标
主要结局
The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).
时间窗: 2 weeks
The scale is classified into 5 steps which are based on the severity of the improvement. EX) noticable improvement: 4-\>1, 3-\>1, slight improvement: 4-\>3, 3-\>2
次要结局
- The number of erosions diagnosed by the gastroscope(2 weeks)
- The severity of the digestive symptoms (Scale of 1 to 5)(2 weeks)