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The Effect of Naloxone and Methylnaltrexone on Esophageal Sensitivity in Health

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ClinicalTrials.gov Identifier: NCT03014843
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Endogenous and Esophageal Sensitivity Drug: Naloxone Drug: Methylnaltrexone Bromide Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Naloxone and Mehtylnaltrexone on Esophageal Sensitivity in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled Study
Study Start Date : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Naloxone
Administration of a centrally acting µ-opioid receptor antagonist Naloxone (20µg/kg/h intravenous infusion after 0.4mg bolus) to investigate the effect of esophageal sensitivity assessed by multimodal esophageal stimulation.
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)
Other Name: Naloxon, B.Braun

Active Comparator: Methylnaltrexone bromide
Administration of a peripherally acting µ-opioid receptor antagonist Methylnaltrexone (12mg/0.6mL subcutaneous injection) to investigate the effect of esophageal sensitivity assessed by multimodal esophageal stimulation.
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 Name: Relistor

Placebo Comparator: Placebo
Administration of placebo injection (1mL 0.9% saline IV or 0.6 IM) as a control condition to compare to the administration of naloxone or methylnaltrexone bromide in the multimodal esophageal stimulation protocol.
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
Other Name: Saline solution (0.9% NaCl)




Primary Outcome Measures :
  1. Measurement of changes in esophageal sensitivity after IV naloxone or IM methylnaltrexone administration [ Time Frame: 3 sessions per HV with at least one week interval, duration of each session: approximately 2 hours. Temperature stimulation: 30 minutes ]
    Investigation of the effect of Naloxone and methylnaltrexone-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the Temperature values (°C) of the stimulation tests between the placebo and naloxone and methylnaltrexone condition to see if CRH affects the sensitivity to increasing temperature

  2. Measurement of changes in esophageal sensitivity after IV naloxone or IM methylnaltrexone administration [ Time Frame: 3 sessions per HV with at least one week interval, duration of each session: approximately 2 hours. Mechanical stimulation: 30 minutes ]
    Investigation of the effect of Naloxone and methylnaltrexone-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the balloon volumes (volume in ml) of the stimulation tests between the placebo and Naloxone and methylnaltrexone condition to see if Naloxone and methylnaltrexone affect the sensitivity to increasing balloon volume.

  3. Measurement of changes in esophageal sensitivity after IV naloxone or IM methylnaltrexone administration [ Time Frame: 3 sessions per HV with at least one week interval, duration of each session: approximately 2 hours. Electrical stimulation: 30 minutes ]
    Investigation of the effect of Naloxone and methylnaltrexone-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the tolerated intensity of the electrical pulses (mA) of the stimulation tests between the placebo and Naloxone and methylnaltrexone condition to see if Naloxone and methylnaltrexone affect the sensitivity to increasing electrical pulses.

  4. Measurement of changes in esophageal sensitivity after IV naloxone or IM methylnaltrexone administration [ Time Frame: 3 sessions per HV with at least one week interval, duration of each session: approximately 2 hours. Chemical stimulation: 30 minutes ]
    Investigation of the effect of Naloxone and methylnaltrexone-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the volume of infused acid (ml) of the stimulation tests between the placebo and Naloxone and methylnaltrexone condition to see if Naloxone and methylnaltrexone affect the sensitivity to acid infusion.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 60 years old
  • No history of gastrointestinal symptoms or complaints

Exclusion Criteria:

  • A history of allergic reaction to naloxone or methylnaltrexone bromide or multiple allergies to several foods and drugs.
  • Pregnancy, lactation.
  • Concomitant administration of monomine oxidase inhibitors (MAOI), verapamil or diltiazem or medications affecting esophageal motility.
  • Significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic).
  • Prior history of esophageal, Ear-Nose-Troat or gastric surgery or endoscopic anti-reflux procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014843


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Jan Tack, MD, PhD KU Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03014843    
Other Study ID Numbers: S54661
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Esophagal sensitivity, GERD, endogenous opiods
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Bromides
Naloxone
Methylnaltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents