Status:
COMPLETED
Mirtazapine Versus Placebo in Functional Dyspepsia
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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
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 ...
Eligibility Criteria
Inclusion
- Functional dyspepsia according to Rome II criteria
- Weight loss of \> 5% body weights
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01240096
Start Date
September 1 2006
End Date
September 11 2012
Last Update
July 1 2024
Active Locations (1)
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1
University Hospitals
Leuven, Flanders, Belgium, 3000