Functional Dyspepsia | Mirtazapine Versus Placebo in Functional Dyspepsia
Functional Dyspepsia research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MirtazapineMirtazapine 15 mg daily
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Mirtazapinemirtazapine 15 mg daily
PlaceboPlacebo once daily
Start Date: September 2006
Completed Date: December 2011
Phase: Phase 4
Primary Outcome: Difference in dyspepsia symptom scores week 8 versus week 0
Secondary Outcome: Individual symptom severities
Study sponsors, principal investigator, and references
Principal Investigator: Jan Tack, M.D., Ph.D.
Lead Sponsor: Universitaire Ziekenhuizen Leuven