INFLUENCE OF NALOXONE AND METHYLNALTREXONE ON INTERDIGESTIVE GASTROINTESTINAL MOTILITY AND HUNGER SCORES IN MAN. - MNTX

Conditions: healthy volunteersnone
this is a physiological study to investigate the influence of opioid antagonism on the interdigestive motor activity of the proximal gastrointestinal tract, hunger scores and plasma gastrointestinal hormone levels

Registration Number: EUCTR2010-020169-26-BE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 control<br>the interdigestive motor activity of the proximal gastrointestinal tract, hunger scores and plasma gastrointestinal hormone levels in man we set out to compare the effect of naloxone vs. methylnaltrexone during a small bowel manometry experiments to be taken four times:<br>After an overnight fast a SB manometry study will be taken. Twenty minutes after the passage of a spontaneous phase 3, methylnaltrexone or saline, naloxone or saline will be administered. Motility recording will be continued until the passage of 2 more activity fronts or for a maximum of 34 hours after drug administration.<br>During throughout the study hunger scores asssessd by VAS questionnaire and plasma ghrelin, motilin and obestatin levels will be collected. ;Secondary Objective: none;Primary end point(s): role of peripheric opioid receptors on interdigestive gastrointestinal motility and hunger.

Secondary Outcome Measures