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OpenTrials
Completed

NCT Number: NCT03402984

Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jan Tack

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acotiamide

Drug

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

Placebo oral tablet

Drug

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

Primary outcomes

  1. Gastric accommodation

    Time frame: Gastric pressure was measured until 1 hour after the start of the liquid meal. Liquid meal started 10 minutes after medication/placebo intake

    Relaxation of the stomach upon food intake

Secondary outcomes

  1. Gastric emptying

    Time frame: Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid

    Gastric emptying was assess by a 13C-octanoid acid breath test

  2. Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm

    Time frame: assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2018
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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