Effect of naloxone and methylnaltrexone on satiety, gastric sensitivity, and accommodation to food in healthy volunteers.

Phase 1

• Conditions: healthy volunteersnone; this is a physiological study to investigate the influence of opioid antagonism on gastric sensorimotor function

• Registration Number: EUCTR2009-017193-20-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-07
• Study Completion: 2010-05-11
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1)A drinking test to determine appetite and satiety.<br>2)A barostat study to investigate gastric sensitivity to distension, basal muscle tone, and gastric accommodation to a meal.<br>3)An intragastric pressure measurement during nutrient drink infusion to assess gastric accommodation during food intake.<br>;Secondary Objective: none;Primary end point(s): liquid nutrient tolerance to reach maximum satiation