NCT00764374已完成3 期
A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 412
- 主要终点
- Subject's global assessment
研究概览
简要总结
To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent
- •postprandial fullness
- •early satiation
- •upper abdominal pain
- •upper abdominal discomfort
- •Patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (At least one symptom of either postprandial fullness or early satiation should be included.)
- •Patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent
- •upper abdominal pain
- •upper abdominal discomfort
- •postprandial fullness
- •bloating in the upper abdomen
- •early satiation
- •Outpatient
排除标准
- •Patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, Barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent
- •Patient showing heartburn within 12 weeks before obtaining consent
- •Patient complicated by irritable bowel syndrome
- •Patient complicated by diabetes mellitus requiring medication
- •Patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life
- •Patient complicated by depression (including suspected cases) or sleep disturbance
研究组 & 干预措施
1
Experimental
干预措施: YM443 (Drug)
结局指标
主要结局
Subject's global assessment
时间窗: Every week
次要结局
- Laboratory tests, resting(At 0, 4, 12, 24, 36, 48 week)
- 12-lead ECG(At 0, 24 and 48 week)
- Adverse events(During treatment)
- Disappearance rate of symptoms(Every week)
研究者
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