Status:
TERMINATED
ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model
Lead Sponsor:
Prof Dr Jan Tack
Conditions:
Gastric Motility
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
It has been demonstrated that the VIPUN Gastric Monitoring System (GMS) can discriminate healthy physiological and pharmacologically-inhibited gastric motility, using a codeine-model in healthy adults...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- Aged between and including 18 and 65 years
- BMI between and including 18 and 30
- Understand and able to read Dutch
- In good health on the basis of medical history
- Refrains from herbal, vitamin and other dietary supplements on the day of the visits
Exclusion
- Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
- Using any medication that might affect gastric function or visceral sensitivity
- Known / suspected current use of illicit drugs
- Known psychiatric or neurological illness
- Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
- History of heart or vascular diseases like irregular heartbeats, angina or heart attack
- Nasopharyngeal surgery in the last 30 days
- Suspected basal skull fracture or severe maxillofacial trauma
- History of thermal or chemical injury to upper respiratory tract or esophagus
- Current esophageal or nasopharyngeal obstruction
- Known coagulopathy
- Known esophageal varices
- Pregnant or breastfeeding women
- Have known side-effects/allergic reactions when taking erythromycin or other macrolide antibiotics (such as azithromycin, clarithromycin)
- Kidney disease
- Liver disease
- Myasthenia gravis
- QT prolongation (QT ≥400 ms) at the screening
- Cardiac arrhythmia or heart failure
- History of C. difficile infection
- Family history of QT prolongation, sudden cardiac death or other heart problems
- Recent vaccinations with live bacterial vaccines (such as typhoid vaccine)
- Concomitant medication use
Key Trial Info
Start Date :
September 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04066231
Start Date
September 7 2019
End Date
March 10 2020
Last Update
August 12 2020
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000