functional dyspepsia diagnosed according to international consensus criteria ("Rome II criteria") MedDRA version: 8.1 Level: LLT Classification code 10013948 Term: Dyspepsia and other specified disorders of function of stomach
Conditions
Interventions
Trade Name: Remergon Soltab 15 mg
Product Name: mirtazapine
Pharmaceutical Form: Orodispersible tablet
Pharmaceutical form of the placebo: Orodispersible tablet
Route of administration of the placebo:
Sponsors
University Hospitals KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: functional dyspepsia diagnosed according to international consensus criteria ("Rome II criteria") 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. organic gastro-intestinal disorders (for example oesophagitis, peptic ulcer, gastritis) 2. current psychiatric disorders (mood & anxiety disorders, eating disorders, psychosis) 3. intake of prokinetic and/or spasmolytic drugs (PPI allowed) 4. intake of antidepressants (SSRI, TCA) and/or neuroleptics during the past two months 5. intake of analgetics (paracetamol allowed) 6. history of major abdominal surgery 7. pregnancy or lactation 8. recent exposure to significant radiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to provide evidence for a putative beneficial effect of mirtazapine on a global dyspepsia symptom score, compared to placebo;Secondary Objective: to provide evidence for a putative beneficial effect of mirtazapine on individual dyspeptic symptom scores and health-related quality of life scores, compared to placebo;Primary end point(s): 1. improvement on global dyspepsia symptom score after 8 weeks 2. responder status on overall treatment evaluation after 8 weeks | — |
Countries
Belgium
Outcome results
None listed