ANTERO-4: A Clinical Investigation of the Effects of Erythromycin on Gastric Motility, Assessed With the VIPUN Gastric Monitoring System in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- GBMI baseline
研究概览
简要总结
It has been demonstrated that the VIPUN Gastric Monitoring System (GMS) can discriminate healthy physiological and pharmacologically-inhibited gastric motility, using a codeine-model in healthy adults (S60320 / AFMPS80M0687).
Erythromycin is a gastroprokinetic agent, known to stimulate gastric contractility. A single dose of 200 mg erythromycin has been shown to induce a prolonged period of enhanced phasic contractile activity.
The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults.
The performance of the VIPUN GMS can be enhanced by data-driven optimization of the VIPUN Motility Algorithm, used to quantify gastric motility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Aged between and including 18 and 65 years
- •BMI between and including 18 and 30
- •Understand and able to read Dutch
- •In good health on the basis of medical history
- •Refrains from herbal, vitamin and other dietary supplements on the day of the visits
排除标准
- •Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
- •Using any medication that might affect gastric function or visceral sensitivity
- •Known / suspected current use of illicit drugs
- •Known psychiatric or neurological illness
- •Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
- •History of heart or vascular diseases like irregular heartbeats, angina or heart attack
- •Nasopharyngeal surgery in the last 30 days
- •Suspected basal skull fracture or severe maxillofacial trauma
- •History of thermal or chemical injury to upper respiratory tract or esophagus
- •Current esophageal or nasopharyngeal obstruction
- •Known coagulopathy
- •Known esophageal varices
- •Pregnant or breastfeeding women
- •Have known side-effects/allergic reactions when taking erythromycin or other macrolide antibiotics (such as azithromycin, clarithromycin)
- •Kidney disease
- •Liver disease
- •Myasthenia gravis
- •QT prolongation (QT ≥400 ms) at the screening
- •Cardiac arrhythmia or heart failure
- •History of C. difficile infection
- •Family history of QT prolongation, sudden cardiac death or other heart problems
- •Recent vaccinations with live bacterial vaccines (such as typhoid vaccine)
- •Concomitant medication use
研究组 & 干预措施
VIPUN GMS
Single arm study.
干预措施: VIPUN GMS (Device)
VIPUN GMS
Single arm study.
干预措施: Erythromycin Lactobionate (Drug)
结局指标
主要结局
GBMI baseline
时间窗: t = 0 - 119 minutes
Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1.
GBMI120 - 139
时间窗: t = 120 - 139 minutes
Motility during erythromycin administration. Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1.
次要结局
- Seriousness of adverse (device) events/effects(t = 0 - 240 minutes)
- GBMI140-240(t = 140 - 240 minutes)
- Relatedness of adverse (device) events/effects(t = 0 - 240 minutes)
- Incidence of protocol deviations related to the investigational medical device(t = 0 - 240 minutes)
- Symptoms(t = 0 - 240 minutes)
- Incidence of adverse events(t = 0 - 240 minutes)
- Severity of adverse (device) events/effects(t = 0 - 240 minutes)
- Incidence of device deficiencies of the investigational medical device(t = 0 - 240 minutes)
研究者
Prof Dr Jan Tack
Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator
Universitaire Ziekenhuizen KU Leuven