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The Effect of Chlorpromazine on Esophageal Sensitivity in Healthy Volunteers.

NCT03183310 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-06-12

No results posted yet for this study

Summary

The effect of chlorpromazine (Largactil) on esophageal sensitivity will be investigated in this study. Overnight fasted subjects will be asked to fill out 2 questionnaires to assess the emotional status before their onset of the stimulation tests. The multimodal stimulation probe will be positioned through the mouth in the distal esophagus.

After the ingestion of the stimulation probe, 10mg of chlorpromazine or placebo (saline) will be slowly administered via intravenous injection. Hereafter the multimodal stimulation tests will be initiated.

Esophageal sensitivity will be assessed by performing thermal, mechanical, electrical and chemical stimulation of the esophagus. The chlorpromazine condition will be compared with a placebo condition, this will be organised on 2 separate study visits in a randomised order.

Conditions

  • Esophageal Reflux

Interventions

DRUG

Chlorpromazine

an intravenous bolus injection of Chlorpromazine will be administered . After an incubation period of 15 minutes esophageal sensitivity will be assessed by multimodal stimulation to evaluate the effect of dopamine antagonism on esophageal sensitivity

DEVICE

Multimodal stimulation probe

The multimodal esophageal probe allows to perform 4 types of stimulations in the esophagus (thermal, mechanical, electrical and chemical stimulation). These 4 modalities will be evaluated to assess esophageal sensitivity.

DRUG

Placebo - Concentrate

an intravenous bolus injection of saline (NaCl 0.9%) will be administered . After an incubation period of 15 minutes esophageal sensitivity will be assessed by multimodal stimulation.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, MD, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Belgium

Study Locations

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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 NCT03183310 on ClinicalTrials.gov