TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial
NCT ID: NCT03555188
Last Updated: 2023-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2018-03-29
2020-09-10
Brief Summary
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Detailed Description
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Other symptoms of IBS-D include frequent, loose, or watery stools with associated urgency, which can severely limit socialising, travelling, and eating out, resulting in a reduced quality of life and work productivity.
The primary aim of the study is to determine the effectiveness and safety of the use of ondansetron in patients with the symptoms of IBS-D including urgency, looseness of stool, frequency of defecation and abdominal discomfort. Ondansetron belongs to a class of drug known as 5HT3RAs and a recent meta-analysis shows that 5HT3RAs is an effective treatment for IBS-D, improving stool consistency and reducing frequency and urgency of defecation.
400 patients with IBS-D will be randomised on a 1:1 basis to receive either Ondansetron or Placebo. Both treatments will be administered in oral doses of between 4-24mg daily for 12 weeks. Dose titration will be undertaken in the first two weeks of the study to avoid constipation.
The primary outcome of response will be assessed at 12 weeks post randomisation using patient reported data on daily stool frequency and abdominal pain.
If ondansetron is effective in the trial, it could easily be widely adopted since it is an inexpensive, safe, and generic drug. By providing an effective treatment, it could not only reduce patient symptoms, but also reduce costs of repeated referral and investigation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ondansetron
Taken orally 4mg-24mg daily for 12 weeks. Dose to be amended throughout according to symptoms.
Ondansetron
Ondansetron is a highly selective receptor antagonist (5-HT3RA)
Placebo
Taken orally 4mg-24mg daily for 12 weeks. Dose to be amended throughout according to symptoms.
Ondansetron
Ondansetron is a highly selective receptor antagonist (5-HT3RA)
Interventions
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Ondansetron
Ondansetron is a highly selective receptor antagonist (5-HT3RA)
Eligibility Criteria
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Inclusion Criteria
2. Considered fit for study participation.
3. Meeting Rome IV criteria for IBS-D
4. Aged ≥ 18 years
5. Undergone standardised workup to exclude the following alternative diagnoses:
1. Microscopic colitis (colonoscopy or flexible sigmoidoscopy),
Exclusion Criteria
4. Coeliac disease (tTG or duodenal biopsy)
6. Patients of child bearing potential or with partners of child bearing potential must agree to use methods of medically acceptable forms of contraception during the study and for 90 days after completion of study drug, (e.g. implants, injectable, combined oral contraceptives, barrier methods, true abstinence (when this is in line with the preferred and usual lifestyle of the patient) or vasectomised partners).
7. For women of child bearing potential, a negative pregnancy test should be performed within 72 hours of confirmation of eligibility.
8. Weekly average worst pain score \>= X on a 0 to 100 point scale \<\<redacted to prevent patient bias\>\>.
9. Any stools with a consistency of X on the Bristol Stool Form score (BSFS) for X day per week\<\<redacted to prevent patient bias\>\>.
1. Gastrectomy
2. Intestinal resection
3. Other known organic GI diseases (e.g. Inflammatory bowel disease - Crohns disease, Ulcerative colitis.)
4. Unable or unwilling to stop restricted medication including regular loperamide, antispasmodics (e.g. buscopan, mebeverine, peppermint oil, alverine citrate), eluxadoline, tricyclic antidepressant doses \>30mg/day or other drugs likely in the opinion of the investigator to alter bowel habit. These medicines should be discontinued for a 7 day washout period prior to registration. Note: Intermittent loperamide will be permitted but only as rescue medication
5. QTc interval ≥450msec for men and ≥470msec for women. Assessed within the last 3 months by a 12-lead ECG.
6. Previous chronic use of ondansetron or contraindications to it (rare as per BNF)
7. Pulse, Blood pressure, FBC or LFTs outside the normal ranges according to the site's local definition of normal. Assessed within the last 3 months.Note: Minor rises in ALT (\<2 x upper limit of normal) will be acceptable but the patient's GP will be informed if they remain elevated at end of the study.
8. Women who are pregnant or breastfeeding
9. Patients currently participating or who have been in an IMP trial in the previous three months where the use of the IMP may cause issues with the assessment of causality in this study.
10. Currently taking SSRIs or tricyclic antidepressants (unless at a stable dose for at least 3 months and with no plan to change the dose during the study).
11. Currently taking and unwilling or unable to stop any of the prohibited medications.\*
\*Prohibited medications - Apomorphine \& tramadol which interact with ondansetron. Caution should be taken with patients on QT prolonging drugs and cardio toxic drugs. These patients should be reviewed by the PI to determine if they are suitable for the study.
12. Patients with stools of consistency X on the Bristol Stool Form score (BSFS) for X days a week \<\<redacted to prevent patient bias\>\>.
18 Years
100 Years
ALL
No
Sponsors
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Barnsley Hospital NHS Foundation Trust
OTHER
Barts & The London NHS Trust
OTHER
County Durham and Darlington NHS Foundation Trust
OTHER_GOV
Flinders University
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
London North West Healthcare NHS Trust
OTHER
NHS Lothian
OTHER_GOV
Queen Mary University of London
OTHER
Sandwell & West Birmingham Hospitals NHS Trust
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
University College London Hospitals
OTHER
University Hospitals of North Midlands NHS Trust
OTHER
Manchester University NHS Foundation Trust
OTHER_GOV
University of Manchester
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Leeds
OTHER
Responsible Party
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Principal Investigators
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Robin Spiller
Role: STUDY_CHAIR
University of Nottingham
Locations
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Barnsley Hospital NHS Foundation Trust
Barnsley, , United Kingdom
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, , United Kingdom
County Durham and Darlington NHS Foundation Trust
Durham, , United Kingdom
Westen General Hosptal, Edinburgh
Edinburgh, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
London North West NHS Foundation Trust
London, , United Kingdom
Queen Mary, University of London
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Salford Royal Hospital
Manchester, , United Kingdom
University Hospital of South Manchester
Manchester, , United Kingdom
SouthTees Hospitals NHS FoundationTrust
Middlesbrough, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke, , United Kingdom
Countries
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References
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Gunn D, Topan R, Barnard L, Fried R, Holloway I, Brindle R, Corsetti M, Scott M, Farmer A, Kapur K, Sanders D, Eugenicos M, Trudgill N, Whorwell P, Mclaughlin J, Akbar A, Houghton L, Dinning PG, Aziz Q, Ford AC, Farrin AJ, Spiller R. Randomised, placebo-controlled trial and meta-analysis show benefit of ondansetron for irritable bowel syndrome with diarrhoea: The TRITON trial. Aliment Pharmacol Ther. 2023 Jun;57(11):1258-1271. doi: 10.1111/apt.17426. Epub 2023 Mar 3.
Other Identifiers
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15/74/01
Identifier Type: -
Identifier Source: org_study_id
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