Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Acotiamide
* Drug: Placebo Oral Tablet


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric motility, Gastric emptying