Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Healthy

Treatments

Drug: Acotiamide

Drug: Placebo Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT03402984

Acotiamide1

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.