Mirtazapine Versus Placebo in Functional Dyspepsia

Phase 4

Completed

• Conditions: Functional Dyspepsia
• Interventions: Drug: Mirtazapine

• Registration Number: NCT01240096
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Study Timeline

• Study Start: 2006-09-01
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Primary Completion: 2011-08-01
• Study Completion: 2012-09-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirtazapine	Mirtazapine	mirtazapine 15 mg daily
Placebo	Mirtazapine	Placebo once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospitals; 🇧🇪 Leuven, Vlaanderen, Belgium