Amisulpride versus Placebo in Functional Dyspespia with delayed gastric emptying
- Conditions
- delayed gastric emptyingMedDRA version: 12.1Level: LLTClassification code 10012199Term: Delayed gastric emptying
- Registration Number
- EUCTR2009-010547-13-BE
- Lead Sponsor
- ZLeuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
delayed gastric emptying for solids proven with a gastric emptying test (t1/2 > 75 minutes)
age between 18 and 70 years
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) yes
F.1.3.1 Number of subjects for this age range
organical gastro-enterological pathology
current major psychiatric pathology
prolonged QT on ECG
intake of medication which may induce 'torsades de pointes' or 'hypokalemia'
intake of prokinetics
intake of more than one antidepressant (SSRI and TCA) or intake of an instable dose of an antidepressant during the last 3 months
intake of neuroleptics
pregnancy or lactation
a medical history with major abdominal chirurgy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method