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

The effect of mirtazapine (REMERGON®) on gastric motility and satiation in healthy subjects

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004862-89-BE

Enrollment

Registered

2015-01-12

Start date

2015-02-16

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Interventions

Trade Name: REMERGON Product Name: mirtazapine Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mirtazapine CAS Number: 61337-67-5 Other descriptive name: mirtazapine Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Belgium

Contacts

Public ContactFlorencia Carbone

KuLeuven

florencia.carbone@med.kuleuven.be003216377535

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026