NCT01719575已完成4 期
A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- gastric fuction of Motilitone
研究概览
简要总结
The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no gastrointestinal symptoms
- •no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy
- •written informed consent
排除标准
- •pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception
- •history of abdominal surgery that may influence gastrointestinal motility
- •gastrointestinal hemorrhage, mechanical ileus, enterobrosis
- •irritable bowel syndrome, inflammatory bowel disease
- •severe disturbance of liver, kidney, heart,lung,blood and endocrine
- •psychoneurosis, alcoholism, drug dependence
- •medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks
研究组 & 干预措施
Placebo
Other
take placebo three times daily for the first week After 7 day wash-out period, take motilitone 30mg three times daily for the second week
干预措施: Placebo (Drug)
Motilitone
Other
take motilitone 30mg three times daily for the first week After 7 day wash-out period, take placebo three times daily for the second week
干预措施: Motilitone (Drug)
结局指标
主要结局
gastric fuction of Motilitone
时间窗: 3 weeks
gastric emptying time on day 4 by scintigraphic imaging
gastric function of Motilitone
时间窗: 3 weeks
fasting and postprandial gastric volume on day 7 by single photon emission computed tomography
次要结局
- adverse events of Motilitone(3 weeks)
- small bowel function of Motilitone(3 weeks)
- Colon function of Motilitone(3 weeks)
研究者
研究点 (1)
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