What is this study?
We are interested to see whether the drug, ondansetron, can improve symptoms of diarrhoea in patients with irritable bowel syndrome. To find out if it works, this study will compare the ondansetron to a dummy treatment called a placebo.
- Attend your hospital appointment to undergo some assessments to find out more about your IBS and see if it is appropriate for you to take part in the study
- Attend your hospital up to 5 more times over 16 weeks.
- Complete a diary to record the details of your bowel movements, your abdominal pain and any side effects.
- Respond to 2 text messages every day (optional) to let us know about your bowel movements and abdominal pain.
- Take your study medication for 12 weeks and do not take any new medication or start a new diet
- You will also be asked, if you agree to provide blood, stool or biopsies and undergo more detailed assessment to help the researchers better understand IBS and how the drug works. These are optional.
As with many drugs, the effect of this treatment on an unborn child are unknown; therefore if you are pregnant, breast-feeding, or if you intend to become pregnant during the study you will not be able to take part. All participants will also be required to use a reliable form of contraception during the study and at least 90 days after treatment has finished.
Will my taking part in this study be kept confidential?
The information needed for study purposes will be collected on paper forms or via a text message. Data will be sent from your hospital to the Clinical Trials Research Unit (CTRU) at the University of Leeds. You will be allocated a study number, which will be used along with your date of birth and initials to identify you on each paper form. Your full name will be included on your consent form and a copy of this will be sent to the CTRU by fax, standard Royal Mail post or email. This information collected about you will be handled strictly in accordance with the consent that you have given and will not be accessed by any other personnel. Your data will be entered onto a secure database held at the CTRU in accordance with the 2018 Data Protection Act.
Hospitals Participating in the TRITON Clinical Trial
This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or the Department of Health. The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland