NCT00996788已完成3 期
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
研究概览
简要总结
To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who
- •are 18 - 80 years old
- •have symptoms of dyspepsia that need endoscopic examination
- •are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
- •are able to give informed concern
排除标准
- •Patients who
- •are treated with drugs that induce gastritis/ulcer, such as: NSAID
- •are chronic alcoholism,
- •are drug abuser
- •are contraindicated for endoscopy examination
- •has erosive or ulcerative esophagitis
- •has peptic ulcer that has been confirmed by endoscopy
- •has pyloric stenosis
- •has active gastrointestinal bleeding
- •has major absorption disorder
- •has history of gastric surgery
- •with renal disorder (creatinine > 2 mg/dL)
- •with liver disease ( SGOT, SGPT, bilirubin)
- •have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count)
- •are suffering from congestive gastropathy due cirrhosis
- •are suffering from congestive heart disease
- •are pregnant or giving breast feeding
- •are hypersensitive to Rebamipide
- •are treated with gastroprotective drugs such as : teprenone, sucralfate.
- •are treated with acid suppressing medicine (H2A, PPI)
- •are treated with antibiotics, mesalazine (Salofalk)
研究组 & 干预措施
Rebamipide
Experimental
Rebamipide 100 mg tid for 28 days
干预措施: Rebamipide (Drug)
结局指标
主要结局
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
时间窗: 2 times (at day-0 and day-28)
次要结局
- To confirm the improvement of dyspepsia syndrome(3 times (at day-0, day-7 and day-28))
研究者
研究点 (1)
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