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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


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

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