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The Effect of Naloxone and Methylnaltrexone on Esophageal Sensitivity in Health

NCT03014843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-01-09

No results posted yet for this study

Summary

The aim of this study was to investigate the effect of naloxone (IV or IM administration) and methylnaltrexone (subcutaneous administration) on esophageal sensitivity, in a group of healthy volunteers in order to evaluate the role of endogenous opiods in symptom perception in gastro-esophageal reflux disease. Esophageal sensitivity was assessed by using a multimodal esophageal stimulation protocol where sensitivity to thermal, mechanical, electrical and chemical stimulation was tested.

Conditions

  • Endogenous and Esophageal Sensitivity

Interventions

DRUG

Naloxone

20µg/kg/h intravenous infusion after 0.4mg bolus of Naloxone and 0.6mL IM NaCl (0.9%) injection (this step is necessary to keep the subject blinded for the condition since nalaxone and methylnaltrexone have different administration routes)

DRUG

Methylnaltrexone Bromide

12mg/0.6mL subcutaneous injection and 1mL bolus of NaCl (0.9%) followed by intravenous infusion (this step is necessary to keep the subject blinded for the condition since nalaxone and methylnaltrexone have different administration routes)

OTHER

Placebo

0.6 mL of NaCl 0.9% will be injected IM and 1mL bolus injection of NaCl(0.9%) will be administered IV followed by IV NaCl 0.9% infusion

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, MD, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03014843 on ClinicalTrials.gov