Acotiamide Affects Antral Motility, But Has no Effect on Fundic Motility, Gastric Emptying or Symptom Perception in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gastric accommodation
研究概览
简要总结
Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date, the exact mechanism of action of acotiamide is incompletely elucidated.
The aim of this study was to examine the effect of acotiamide on gastric motility, gastric emptying rate and gastrointestinal symptom perception in healthy participants in a randomized, placebo-controlled, cross-over study design. Participants were treated with acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period. At the end of each treatment period, gastric emptying and motility were assessed on two consecutive study days. During gastric motility assessment, epigastric symptom scores were collected at multiple time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18-60 years old.
- •Participant must provide witnessed written informed consent prior to any study procedures being performed.
- •Exclusion criteria:
- •Age > 60 years old.
- •severely decreased kidney function.
- •severely decreased liver function.
- •severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
- •severe lung disease.
- •severe psychiatric illness or neurological illness.
- •any gastrointestinal disease.
- •any dyspeptic symptoms.
- •pregnant or breastfeeding.
排除标准
- 未提供
研究组 & 干预措施
Acotiamide
Acotiamide 100 mg t.i.d. for 3 weeks. Intake of medication 10 minutes before meal.
干预措施: Acotiamide (Drug)
Placebo
Placebo tablets, t.i.d. for 3 weeks. Intake of placebo 10 minutes before meal.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Gastric accommodation
时间窗: Gastric pressure was measured until 1 hour after the start of the liquid meal. Liquid meal started 10 minutes after medication/placebo intake
Relaxation of the stomach upon food intake
次要结局
- Gastric emptying(Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid)
- Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm(assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal)