Mirtazapine Versus Placebo in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01240096
• Other study ID #: S50181
• Status: Recruiting
• Phase: Phase 4
• First received: November 12, 2010
• Last updated: November 12, 2010
• Start date: September 2006
• Est. completion date: December 2011

Study information

• Verified date: November 2010
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Jan Tack, M.D., Ph.D.
• Phone: +3216344225
• Email: jan.tack[@]med.kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Mirtazapine
Mirtazapine 15 mg daily

Locations

Country	Name	City	State
Belgium	University Hospitals	Leuven	Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Individual symptom severities	Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint	Week 8 compared to week 0	No
Secondary	Nepean dyspepsia index for quality of life in functional dyspepsia	Use of the validated NDI.	Week 8 compared to week 0	No

External Links

•   Website Research Group