NCT03402984

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

January 10, 2018

Last Update Submit

January 10, 2018

Conditions

Healthy

Keywords

Gastric motilityGastric emptying

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Gastric emptying

    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

Study Arms (2)

Acotiamide

EXPERIMENTAL

Acotiamide 100 mg t.i.d. for 3 weeks. Intake of medication 10 minutes before meal.

Drug: Acotiamide

Placebo

PLACEBO COMPARATOR

Placebo tablets, t.i.d. for 3 weeks. Intake of placebo 10 minutes before meal.

Drug: Placebo Oral Tablet

Interventions

AcotiamideDRUG

Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.

Acotiamide
Placebo Oral TabletDRUG

Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age: 18-60 years old.
  • Participant must provide witnessed written informed consent prior to any study procedures being performed.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jan Tack

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 30663175DERIVED

MeSH Terms

Interventions

Z 338

Study Officials

  • Jan Tack, PhD, MD

    UZ Leuven / KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 18, 2018

Study Start

April 1, 2017

Primary Completion

July 30, 2017

Study Completion

December 4, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)