Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)

University of Nottingham

Status and phase

Completed

Phase 4

Conditions

Irritable Bowel Syndrome With Diarrhoea

Treatments

Drug: Placebo

Drug: Ondansetron

Study type

Interventional

Funder types

Other

Identifiers

NCT00745004

08027

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 vasectomised partners)
Patients who are able to give informed consent.

Exclusion criteria

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.