Clinical trial NCT03402984: Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers
Official title: Acotiamide Affects Antral Motility, But Has no Effect on Fundic Motility, Gastric Emptying or Symptom Perception in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Gastric motility
Gastric emptying
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastric accommodation
timeFrame: 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:
measure: Gastric emptying
timeFrame: Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid
measure: Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
timeFrame: assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Jan Tack
Study officials:
affiliation: UZ Leuven / KU Leuven
name: Jan Tack, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.