Mirtazapine Versus Placebo in Functional Dyspepsia

Status Recruiting

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01240096
Study type	Interventional
Source	Universitaire Ziekenhuizen Leuven
Contact	Jan Tack, M.D., Ph.D.
Phone	+3216344225
Email	jan.tack@med.kuleuven.be
Status	Recruiting
Phase	Phase 4
Start date	September 2006
Completion date	December 2011

View Details

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