A Phase 4 interventional study of Mirtazapine in Functional Dyspepsia, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment
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
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
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 35 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
mirtazapine 15 mg daily
Drug: Mirtazapine
Placebo once daily
Drug: Mirtazapine
Mirtazapine 15 mg daily
Also known as: mirtazapine is Remergon
Difference in dyspepsia symptom scores week 8 versus 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).
Time frame: Week 8 compared to week 0
Individual symptom severities
Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint
Time frame: Week 8 compared to week 0
Nepean dyspepsia index for quality of life in functional dyspepsia
Use of the validated NDI.
Time frame: Week 8 compared to week 0
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven