healthy volunteers none
Conditions
Interventions
Trade Name: Narcan
Pharmaceutical Form: Intravenous infusion
CAS Number: 357-08-4
Other descriptive name: NALOXONE HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: e
Sponsors
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers (18-45 years) who have no bowel symptoms and who are in good general health are eligible for the study. 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
Exclusion criteria: • They have relevant underlying disease (cardia, pulmonary, metabolic, kidney or liver disease, …) • They have a history of esophageal or gastric surgery, or recurrent or intermittent upper gastrointestinal symptoms (upper abdominal pain, nausea, vomiting, bothersome fullness or early satiation, heartburn, regurgitation,…) • They have a history of allergy to several types of drugs or food. • They have ever been treated for depression • There is a possibility of becoming pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In order to investigate whether central or peripheral mu-opioid receptors mediate gastric motility and appetite sensations we set out to compare the effect of naloxone vs. methylnaltrexone in three experiments: 1) A drinking test to determine appetite and satiety. 2) A barostat study to investigate gastric sensitivity to distension, basal muscle tone, and gastric accommodation to a meal. 3) An intragastric pressure measurement during nutrient drink infusion to assess gastric accommodation during food intake. ;Secondary Objective: none;Primary end point(s): liquid nutrient tolerance to reach maximum satiation | — |
Countries
Belgium
Outcome results
None listed