NCT00761358已完成3 期
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Zeria Pharmaceutical0 个研究点目标入组 820 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 主要终点
- General impression at last visit in treatment period
研究概览
简要总结
The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent
- •Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)
- •Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent
排除标准
- •Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent
- •Subjects have heartburn in last 12 weeks before obtaining informed consent
- •Subjects with irritable bowel disease (IBS)
- •Subjects with diabetes mellitus requiring treatment
- •Subjects with serious anxiety disorder
- •Subjects with depression and/or sleep disorder
- •Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)
研究组 & 干预措施
Z-338
Experimental
干预措施: Z-338 (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
General impression at last visit in treatment period
时间窗: 4 week
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period
时间窗: 4 week
次要结局
- Individual symptom score(Every week)
- SF-NDI(At 0, 4 week and 4 week after treatment)
- General Impression(Every week)
- Laboratory tests(At 0, 4 week and 4 week after treatment)
- Adverse Event(4 week treatment period and 4 week after treatment)
研究者
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