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Mirtazapine Versus Placebo in Functional Dyspepsia

Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Functional Dyspepsia

Intervention: Mirtazapine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
Jan Tack, M.D., Ph.D., Principal Investigator, Affiliation: University Hospitals Leuven

Overall contact:
Jan Tack, M.D., Ph.D., Phone: +3216344225, Email: jan.tack@med.kuleuven.be

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Difference in dyspepsia symptom scores week 8 versus week 0

Secondary outcome:

Individual symptom severities

Nepean dyspepsia index for quality of life in functional dyspepsia

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Jan Tack, M.D., Ph.D., Phone: +3216344225, Email: jan.tack@med.kuleuven.be

University Hospitals, Leuven, Vlaanderen 3000, Belgium; Recruiting
Jan Tack, M.D., Ph.D., Phone: +3216344225, Email: jan.tack@med.kuleuven.be
Jan Tack, M.D., Ph.D., Principal Investigator
Additional Information

Website Research Group

Starting date: September 2006
Last updated: November 12, 2010

Page last updated: August 23, 2015

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