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Mirtazapine Versus Placebo in Functional Dyspepsia | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT01240096

Mirtazapine Versus Placebo in Functional Dyspepsia

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

Lead sponsor: Universitaire Ziekenhuizen KU Leuven•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Universitaire Ziekenhuizen KU Leuven

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 1, 2024Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment35

Start dateSep 2006

Last updatedJul 1, 2024

Condition

Functional Dyspepsia

Locations shown

University Hospitals

Leuven, Flanders

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions