Mirtazapine Versus Placebo in Functional Dyspepsia
Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss
1 other identifier
interventional
35
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 12, 2010
CompletedFirst Posted
Study publicly available on registry
November 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2012
CompletedJuly 1, 2024
June 1, 2024
4.9 years
November 12, 2010
June 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in dyspepsia symptom scores week 8 versus 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).
Week 8 compared to week 0
Secondary Outcomes (2)
Individual symptom severities
Week 8 compared to week 0
Nepean dyspepsia index for quality of life in functional dyspepsia
Week 8 compared to week 0
Study Arms (2)
Mirtazapine
ACTIVE COMPARATORmirtazapine 15 mg daily
Placebo
PLACEBO COMPARATORPlacebo once daily
Interventions
Eligibility Criteria
You may qualify if:
- Functional dyspepsia according to Rome II criteria
- Weight loss of \> 5% body weights
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals
Leuven, Flanders, 3000, Belgium
Related Publications (1)
Tack J, Ly HG, Carbone F, Vanheel H, Vanuytsel T, Holvoet L, Boeckxstaens G, Caenepeel P, Arts J, Van Oudenhove L. Efficacy of Mirtazapine in Patients With Functional Dyspepsia and Weight Loss. Clin Gastroenterol Hepatol. 2016 Mar;14(3):385-392.e4. doi: 10.1016/j.cgh.2015.09.043. Epub 2015 Oct 30.
PMID: 26538208DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Tack, M.D., Ph.D.
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 12, 2010
First Posted
November 15, 2010
Study Start
September 1, 2006
Primary Completion
August 1, 2011
Study Completion
September 11, 2012
Last Updated
July 1, 2024
Record last verified: 2024-06