Functional Dyspepsia
Conditions
Keywords
Functional dyspepsia, Weight loss, Mirtazapine
Brief summary
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily
Detailed description
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine Two weeks run-in, 8 weeks randomized, 8 weeks open label Assessments include * dyspepsia questionnaire * Nepean dyspepsia index * Daily diary * Vital signs
Interventions
DRUGMirtazapine
Mirtazapine 15 mg daily
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Functional dyspepsia according to Rome II criteria * Weight loss of \> 5% body weights
Exclusion criteria
* Organic GI pathology * History of upper gi tract surgery * Major depression or anxiety * Use of antidepressants in the last 2 months * Prokinetic drugs or spasmolytic drugs * Analgesic use (except paracetamol) * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in dyspepsia symptom scores week 8 versus week 0 | Week 8 compared to week 0 | The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual symptom severities | Week 8 compared to week 0 | Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint |
| Nepean dyspepsia index for quality of life in functional dyspepsia | Week 8 compared to week 0 | Use of the validated NDI. |
Countries
Belgium
Outcome results
None listed