Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-12-04

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Acotiamide

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

Group Type EXPERIMENTAL

Acotiamide

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

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

Interventions

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Acotiamide

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

Intervention Type DRUG

Placebo Oral Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes