Skip to main content
OpenTrials
Completed

NCT Number: NCT01240096

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Dyspepsia Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals

Leuven, Flanders, 3000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mirtazapine

Drug

Mirtazapine 15 mg daily

Other names: mirtazapine is Remergon

Primary outcomes

  1. Difference in dyspepsia symptom scores week 8 versus week 0

    Time frame: Week 8 compared to week 0

    The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998).

Secondary outcomes

  1. Individual symptom severities

    Time frame: Week 8 compared to week 0

    Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint

  2. Nepean dyspepsia index for quality of life in functional dyspepsia

    Time frame: Week 8 compared to week 0

    Use of the validated NDI.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Nov 15, 2010
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.