NCT04066231

ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model

ANTERO-4: A Clinical Investigation of the Effects of Erythromycin on Gastric Motility, Assessed With the VIPUN Gastric Monitoring System in Healthy Adults

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Prof Dr Jan Tack · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Gastric Motility

Interventions

Type	Name	Description
DEVICE	VIPUN GMS	Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).
DRUG	Erythromycin Lactobionate	Test model: Erythromycin has gastroprokinetic properties. 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. Erythromycin Lactobionate infusion: 200 mg i.v. infusion over a period of 20 minutes. Note: Erythromycin is not labeled as a gastroprokinetic agent in Belgium.

Timeline

• Start date: 2019-09-07
• Primary completion: 2020-03-10
• Completion: 2020-03-10
• First posted: 2019-08-26
• Last updated: 2020-08-12

Locations

1 site across 1 country: Belgium