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

The effect of acotiamide on gastric motility and satiation in healthy volunteers - The effect of acotiamide on gastric motility and satiation in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002092-28-BE

Enrollment

Registered

2014-06-05

Start date

2017-04-19

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Funtional gastroenterological disorder: Functional Dyspepsia more specific the postprandial distress syndrome.

Interventions

Trade Name: Acofide Product Name: Acotiamide Product Code: Z-338 Pharmaceutical Form: Tablet INN or Proposed INN: Acotiamide CAS Number: 773092-05-0 Current Sponsor code: Z-338API Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Belgium

Contacts

Public ContactTARGID

KULeuven

florencia.carbone@med.kuleuven.be003216377535

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026