drugset / Trial / NCT03402984

Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

NCT03402984

Completed 20 enrolled Universitaire Ziekenhuizen KU Leuven
RandomizedCrossoverSingle-blindOther

Summary

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.

Timeline

Start
2017-04-01
Primary completion
2017-07-30
Completion
2017-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Acotiamide Small molecule 100 mg

Indications

No indication recorded.