Ondansetron for the treatment of irritable bowel syndrome (IBS) with diarrhoea (IBS-D): identifying the responder
| ISRCTN | ISRCTN22664524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22664524 |
| ClinicalTrials.gov (NCT) | NCT00745004 |
| Clinical Trials Information System (CTIS) | 2008-000623-25 |
| Protocol serial number | 6965 |
| Sponsor | University of Nottingham (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 26/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Klara Garsed
Scientific
Scientific
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional multicentre treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised interventional multicentre trial of ondansetron versus placebo in the treatment of patients with irritable bowel syndrome (IBS) with diarrhoea (IBS-D) |
| Study acronym | Ondansetron for IBS-D |
| Study objectives | Irritable bowel syndrome (IBS) is a common problem, with often distressing symptoms that can result in a reduced quality of life. This is a two centre randomised double blind placebo controlled crossover trial of Ondansetron in IBS-D. The aim is to identify clinical, laboratory, and magnetic resonance imaging (MRI) scan features that will predict response in clinical practice. The primary outcome measure is a change in stool average stool consistency in the last 2 weeks of treatment of Ondansetron versus placebo. |
| Ethics approval(s) | Nottingham Research Ethics Committee 2, 10/11/2008, ref: 08/H0408/134 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Double blind placebo, this is a randomised double blind placebo controlled trial 1. A 1 week screening period where the subject completes a daily stool diary 2. Treatment period 1 (5 weeks) where the subject receives either placebo or 4 mg of ondansetron titrated to a dose of min 4 mg every other day, max 8 mg three times a day 3. A 2 week washout 4.A second treatment period (5 weeks) where the subject receives either placebo or active therapy with ondansetron depending on which therapy was administered in treatment Study Entry: Single Randomisation only |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ondansetron |
| Primary outcome measure(s) |
Difference in average stool consistency in the last 2 weeks of treatment of Ondansetron versus placebo |
| Key secondary outcome measure(s) |
Measured against the primary endpoint in the final 2 weeks of each treatment period: |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Patients with IBS-D meeting the Rome III criteria 2. Patients able to give informed consent 3. Female patients of child bearing potential are willing to use at least one highly effective contraceptive method 4. Aged 18 years and over, either sex |
| Key exclusion criteria | 1. Women who are pregnant or breast feeding 2. Patients unable to stop anti-diarrhoeal drugs 3. Patients currentluy in, or have been in another clinical trial in the previous 3 months |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/01/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/07/2016: Publication reference added.
