The effect of acotiamide on gastric movements and the feeling of satiation during a meal in healthy volunteers

Phase 1

• Conditions: Funtional gastroenterological disorder: Functional Dyspepsia more specific the postprandial distress syndrome.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-002092-28-BE
• Lead Sponsor: KULeuven - TARGID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-05
• Study Completion: 2017-07-27
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Volunteers can participate in this study if:
-They are between 18-60 years old.
-Male and female.
-Volunteer must provide witnessed written informed consent prior to any study procedures being performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Volunteers cannot participate in this study if:
-Have severely decreased kidney function.
-Have severely decreased liver function.
-Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
-Have severe lung disease.
-Have severe psychiatric illness or neurological illness.
-Have any gastrointestinal disease.
-Have any dyspeptic symptoms.
-Women that are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this trial is to investigate the effect of acotiamide in gastric accommodation and satiation during and after meal;Secondary Objective: The secondary objective is to investigate the effect of acotiamide in gastric motility;Primary end point(s): The primary endpoint of this study is to explore the effect of acotiamide in gastric accommodation and satiation compared with placebo;Timepoint(s) of evaluation of this end point: 7 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint of this study is to explore the effect of acotiamide in gastric motility (gastric emptying, gastric contractions) compared to placebo;Timepoint(s) of evaluation of this end point: 7 weeks