NCT00458328已完成2 期
The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound
Zeria Pharmaceutical2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
研究概览
简要总结
Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound
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
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit
- •Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.
排除标准
- •Subjects that heartburn should be the most bothersome symptom
- •Subjects presenting with primary complaints relieved by stool movements (IBS)
- •Subjects with diabetes by treatment
- •Subjects that heartburn should be more than moderate
结局指标
主要结局
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
次要结局
未报告次要终点
研究者
研究点 (2)
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