Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)
Information source: University of Nottingham
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Irritable Bowel Syndrome With Diarrhoea
Intervention: Ondansetron (Drug); Placebo (Drug)
Phase: Phase 4
Sponsored by: University of Nottingham
Official(s) and/or principal investigator(s):
Robin Spiller, Principal Investigator, Affiliation: University of Nottingham
Peter Whorwell, MD, Principal Investigator, Affiliation: University Hospital of South Manchester NHS Foundation Trust
Irritable bowel syndrome is a common condition affecting 1 in 10 of the population. About a
third of these suffer from diarrhoea, which severely impairs their quality of life.
Previous studies in Nottingham have suggested that some patients with diarrhoea may have an
excess of a chemical called serotonin in their gut. Serotonin stimulates secretion and
propulsion in the gut and contributes to diarrhoea. We are interested to see whether a
drug, Ondansetron, which blocks the effect of serotonin, would improve symptoms in patients
with IBS and diarrhoea. We think the drug may work better in people with a specific gene
type so your genetic makeup may be of influence and we would like to test this. Because IBS
symptoms fluctuate, one way to determine whether Ondansetron is effective is to perform a
randomised placebo controlled trial in which neither the patient nor the doctor knows which
medication is being taken in each part of the study.
Official title: Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D): Identifying the "Responder"
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The primary outcome measure is the difference in average stool consistency during the last two week period of Ondansetron compared to placebo treatment.
Secondary outcome: 1) Proportion of patients preferring ondansetron versus placebo 2) Proportion wanting to continue with ondansetron versus placebo 3) Difference between ondansetron and placebo periods.
Minimum age: 18 Years.
Maximum age: 75 Years.
- IBS-D patients meeting the Rome III criteria.
- Male or female aged 18-75 years
- Women of child bearing potential (who have a negative pregnancy test) must agree to
use methods of medically acceptable forms of contraception during the study., (e. g.
implants, injectables, combined oral contraceptives, sexual abstinence or
- Patients who are able to give informed consent.
- Women who are pregnant or breastfeeding
- Patients that, in the opinion of the investigator, are considered unsuitable.
- Patients who have had abdominal surgery which may cause bowel symptoms similar to IBS
(Please note, appendicectomy and cholecystectomy is not an exclusion)
- Patient unable to stop anti-diarrhoeal drugs
- Patients currently participating in another clinical trial or who have been in a
trial in the previous three months
Since many patients will be on SSRIs or tricyclics antidepressants these will not be an
exclusion criteria, provided they have been on medication at least 3 months and that the
dose remains unaltered throughout the study.
Locations and Contacts
University Hospital of South Manchester NHS Foundation Trust, Manchester, Greater Manchester M23 9LT, United Kingdom
University of Nottingham, Nottingham, Nottinghamshire NG7 2UH, United Kingdom
Starting date: January 2009
Last updated: January 23, 2012