NCT01240096

Mirtazapine Versus Placebo in Functional Dyspepsia

Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Mirtazapine	Mirtazapine 15 mg daily

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-08-01
• Completion: 2012-09-11
• First posted: 2010-11-15
• Last updated: 2024-07-01

Locations

1 site across 1 country: Belgium