drugset / Trial / NCT04066231

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

NCT04066231

Terminated 5 enrolled Prof Dr Jan Tack
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2019-09-07
Primary completion
2020-03-10
Completion
2020-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Erythromycin Small molecule 200 mg Intravenous