Status:
COMPLETED
Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Irritable Bowel Syndrome With Diarrhoea
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 Nott...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00745004
Start Date
January 1 2009
End Date
July 1 2011
Last Update
January 24 2012
Active Locations (2)
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1
University Hospital of South Manchester NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M23 9LT
2
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH