Functional Dyspepsia Clinical Trial
Official title:
Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss
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
- dyspepsia questionnaire
- Nepean dyspepsia index
- Daily diary
- Vital signs
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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