Mirtazapine Versus Placebo in Functional Dyspepsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-01

Study Completion Date

2012-09-11

Brief Summary

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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

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Detailed Description

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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

Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mirtazapine

mirtazapine 15 mg daily

Group Type ACTIVE_COMPARATOR

Mirtazapine

Intervention Type DRUG

Mirtazapine 15 mg daily

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Mirtazapine

Intervention Type DRUG

Mirtazapine 15 mg daily

Interventions

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Mirtazapine

Mirtazapine 15 mg daily

Intervention Type DRUG

Other Intervention Names

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mirtazapine is Remergon

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No