Study Results
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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COMPLETED
NA
22 participants
INTERVENTIONAL
2017-09-25
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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Placebo - deflated balloon
VIPUN Balloon Catheter 0.1 deflated
deflation balloon
Placebo
Sirupus Simplex
Placebo - inflated balloon
Placebo
Sirupus Simplex
VIPUN Balloon Catheter 0.1 inflated
VIPUN Balloon Catheter 0.1 inflated
Codeine - delfated balloon
VIPUN Balloon Catheter 0.1 deflated
deflation balloon
Codeine Phosphate
58.8 mg codeïne phosphate
Codeine - inflated balloon
Codeine Phosphate
58.8 mg codeïne phosphate
VIPUN Balloon Catheter 0.1 inflated
VIPUN Balloon Catheter 0.1 inflated
Interventions
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VIPUN Balloon Catheter 0.1 deflated
deflation balloon
Codeine Phosphate
58.8 mg codeïne phosphate
Placebo
Sirupus Simplex
VIPUN Balloon Catheter 0.1 inflated
VIPUN Balloon Catheter 0.1 inflated
Eligibility Criteria
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Inclusion Criteria
* Aged between and including 18 and 65 years
* BMI between and including 18 and 25
* Understand and able to read Dutch
* In good health on the basis of medical history
* Able to return home without driving a vehicle on visit days 1-4
* Will not operate machines on the same day of treatment (visits 1-4)
* Females subjects of childbearing potential are willing to use adequate contraception
* Refrains from herbal, vitamin and other dietary supplements on the day of the visits
Exclusion Criteria
* 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, upper GI or esophageal 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
* History of opioid dependency
* Known severely decreased kidney or liver function
* Pregnant or breastfeeding women (pregnancy test will be performed on females with childbearing potential)
* Known severe lung disease (e.g. asthma or emphysema)
* Have known side-effects/allergic reactions when taking codeine/morphine
* Known diabetic, fructose intolerance or malabsorption of glucose or galactose or sucrose-isomalase insufficiency.
• Known diabetic (saccharose), intolerance to or malabsorption of propylene glycol and methyl- and propylparahydroxybenzoate
• Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Fortimel Energy
18 Years
65 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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UZ Leuven Gasthuisberg
Leuven, , Belgium
Countries
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Other Identifiers
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S60320
Identifier Type: -
Identifier Source: org_study_id
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