NCT01089543
已完成
2 期
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
概览
- 阶段
- 2 期
- 干预措施
- Rabeprazole
- 疾病 / 适应症
- Functional Dyspepsia
- 发起方
- Eisai Co., Ltd.
- 入组人数
- 338
- 主要终点
- Rate of Complete Dyspepsia Symptom Relief
- 状态
- 已完成
- 最后更新
- 12年前
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.
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rabeprazole 10 mg
干预措施: Rabeprazole
Rabeprazole 20 mg
干预措施: Rabeprazole
Rabeprazole 40 mg
干预措施: Rabeprazole
Placebo
干预措施: Placebo
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))
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