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Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea

NCT03833999 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-11-27

No results posted yet for this study

Summary

This is a double-blind, two period, two treatment crossover trial of ondansetron verses placebo studying the effects of ondansetron in the small and large bowel, specifically its effects on the amount of water in the gut, measured by MRI.

Conditions

  • Motility Disorder of Intestine
  • Ondansetron
  • Small Bowel Water

Interventions

DRUG

Ondansetron 8mg

ondansetron, a 5HT3 receptor antagonist used clinically in nausea and vomiting

DIAGNOSTIC_TEST

abdominal MRI

serial MRIs on day 1 and day 3 of the study, at baseline and 2 hours apart 0-6 hours after meal ingestion on day 1 and 0-4 hours after the meal on day 3

DRUG

Lactulose

Participants will receive 20mls lactulose twice daily for 48 hours prior to the third study day

DRUG

Placebo oral capsule

overcoated placebo tablet, identical to the ondansetron

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Robin Spiller · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-06-27
Completion
2019-06-27

Countries

  • United Kingdom

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 NCT03833999 on ClinicalTrials.gov