NCT01039558已完成不适用
Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- We will compare the summations of symptoms score and calculate the response rate
研究概览
简要总结
We will estimate the responses of lansoprazole and ecabet sodium combination therapy and compare with lansoprazole and placebo therapy in patients who need additional therapy after standard proton pump inhibitor treatment for 4week or more in recurrent 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
- Double (Participant, Investigator)
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
- 是
入选标准
- •age 19-75 years
- •patients with typical gastroesophageal symptom or erosive reflux esophagitis on gastroduodenoscopy
- •patients with recurrent gastroesophageal symptom after standard proton pump inhibitor treatment for 4 weeks or more
排除标准
- •patients with gastric ulcer or duodenal ulcer
- •patients with gastric cancer or esophageal cancer
- •pregnant or postpartum women
研究组 & 干预措施
lansoprazole + ecabet sodium
Active Comparator
干预措施: ecabet sodium (Drug)
lansoprazole + ecabet sodium
Active Comparator
干预措施: lansoprazole (Drug)
lansoprazole + placebo
Placebo Comparator
干预措施: lansoprazole (Drug)
lansoprazole + placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
We will compare the summations of symptoms score and calculate the response rate
时间窗: after 4 weeks and 8 weeks
次要结局
- the global response of treatment(after 8 weeks)
研究者
研究点 (1)
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