Status:
COMPLETED
Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
Lead Sponsor:
University of Nottingham
Conditions:
Motility Disorder of Intestine
Ondansetron
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
If participants interested to take part the investigators will ask some questions to check participants are eligible to take part. Part of this involves measuring height, weight and having an electroc...
Eligibility Criteria
Inclusion
- aged 18 or older
- able to give informed consent
Exclusion
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function, congenital long QT syndrome or QTc \>450msecs for males or 470 msecs for female on screening ECG.
- A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
- Intestinal stoma
- Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Will not agree to dietary restrictions required during the MRI study day
- Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
- Inability to lie flat or exceed scanner limits of weight \<120kg
- Poor understanding of English language
- Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM
- Participation in any medical trials for the past 3 months
- Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03833999
Start Date
October 16 2018
End Date
June 27 2019
Last Update
November 27 2019
Active Locations (1)
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1
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH