Inhibition of Gastric Acid Is the Key To Satisfactory Relief of Symptoms and Restoration of the Quality of Life in Patients With Epigastric Pain Related to Non-Ulcer Dyspepsia During Therapy With Esomeprazole
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms
研究概览
简要总结
Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients
详细描述
Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy. Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（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
1
Placebo
干预措施: Placebo (Other)
2
Esomeprazole
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms
时间窗: 8 Weeks
Dyspeptic symptoms severity will be assessed with validated 7-graded diary cards. The diary cards asked "Please state for each day if you have experienced pain or discomfort in the stomach." Measure taken over 7 consecutive days of a 2 week run in and at the end of each therapeutic period.
次要结局
- Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours(8 Weeks)