Mirtazapine Versus Placebo in Functional Dyspepsia

June 28, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaanderen
      • Leuven, Vlaanderen, Belgium, 3000
        • University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo once daily
Drug: Mirtazapine
Mirtazapine 15 mg daily
Other Names:
  • mirtazapine is Remergon
Active Comparator: Mirtazapine
mirtazapine 15 mg daily
Drug: Mirtazapine
Mirtazapine 15 mg daily
Other Names:
  • mirtazapine is Remergon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 8 compared to week 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 8 compared to week 0
Nepean dyspepsia index for quality of life in functional dyspepsia
Time Frame: Week 8 compared to week 0
Use of the validated NDI.
Week 8 compared to week 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Jan Tack, M.D., Ph.D., Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 11, 2012

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (Estimated)

November 15, 2010

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S50181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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