NCT01089543已完成2 期
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 338
- 主要终点
- Rate of Complete Dyspepsia Symptom Relief
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Rabeprazole 10 mg
Experimental
干预措施: Rabeprazole (Drug)
Rabeprazole 20 mg
Experimental
干预措施: Rabeprazole (Drug)
Rabeprazole 40 mg
Experimental
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Rate of Complete Dyspepsia Symptom Relief
时间窗: Up to 8 Weeks (including 7 days prior)
The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.
次要结局
- Rate of Satisfactory Symptom Relief(Up to 8 Weeks (including 7 days prior))
研究者
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