EUCTR2006-003194-27-BEActive, not recruitingPhase 1
mirtazapine versus placebo in functional dyspepsia: a randomized, double-blind, placebo-controlled trial - mirtazapine versus placebo in functional dyspepsia
niversity Hospitals KU Leuven0 sites60 target enrollmentStarted: August 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •functional dyspepsia diagnosed according to international consensus criteria (Rome II criteria)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. organic gastro-intestinal disorders (for example oesophagitis, peptic ulcer, gastritis)
- •2. current psychiatric disorders (mood & anxiety disorders, eating disorders, psychosis)
- •3. intake of prokinetic and/or spasmolytic drugs (PPI allowed)
- •4. intake of antidepressants (SSRI, TCA) and/or neuroleptics during the past two months
- •5. intake of analgetics (paracetamol allowed)
- •6. history of major abdominal surgery
- •7. pregnancy or lactation
- •8. recent exposure to significant radiation
Investigators
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