The effect of mirtazapine (REMERGON®) an tetracyclic antidepressant on gastric movements and satiation in healthy subjects

Phase 1

• Conditions: Functional Dyspepsia; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004862-89-BE
• Lead Sponsor: KULeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Study Completion: 2016-02-23
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Volunteers can participate in this study if:
-They are between 18-60 years old.
-Male and Female
-Volunteer must provide witnessed written informed consent prior to any study procedures being performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

They cannot participate if:
-They are older than 60 years old.
-have severely decreased liver function.
-have severely decreased kidney function.
- have severe lung diseases
-have severe psychiatric illness or neurological illness.
- have dyspeptic symptoms.
-women that are pregnant and or breastfeeding.
- have severe heart disease
- have any gastrointestinal disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to investigate the mechanism of work of mitrazipine (Remergon) in gastric motility and sensivity, and satiation in healthy volunteers.;Secondary Objective: to observe the effect of mirtazapine on gastric accommodation and satiation;Primary end point(s): The endpoint of this study is to observe whether gastric accommodation is improved by this tetracyclic antidepressant. ;Timepoint(s) of evaluation of this end point: After 3 weeks of treatment gastric accommodation will be investigated. The wash-out period for this cross-over study is at least 1 week.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The second endpoint of this study is observe whether nutrient tolerance is improved by this tetracyclic antidepressant. ;Timepoint(s) of evaluation of this end point: After 3 weeks of treatment nutrient tolerance will be investigated. The wash-out period for this cross-over study is at least 1 week.