Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Acotiamide Affects Antral Motility, But Has no Effect on Fundic Motility, Gastric Emptying or Symptom Perception in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Acotiamide; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Jan Tack

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acotiamide; Acotiamide 100 mg t.i.d. for 3 weeks. Intake of medication 10 minutes before meal.	Drug: Acotiamide; Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.
Placebo Comparator: Placebo; Placebo tablets, t.i.d. for 3 weeks. Intake of placebo 10 minutes before meal.	Drug: Placebo Oral Tablet; Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric accommodation	Relaxation of the stomach upon food intake	Gastric pressure was measured until 1 hour after the start of the liquid meal. Liquid meal started 10 minutes after medication/placebo intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying	Gastric emptying was assess by a 13C-octanoid acid breath test	Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm		assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jan Tack, PhD, MD, UZ Leuven / KU Leuven

Publications and helpful links

General Publications

• Masuy I, Tack J, Verbeke K, Carbone F. Acotiamide affects antral motility, but has no effect on fundic motility, gastric emptying or symptom perception in healthy participants. Neurogastroenterol Motil. 2019 Apr;31(4):e13540. doi: 10.1111/nmo.13540. Epub 2019 Jan 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): December 4, 2017

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Gastric emptying; Gastric motility
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Gastrointestinal Agents; Cholinesterase Inhibitors; Z 338
• Other Study ID Numbers: Acotiamide1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No