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 |
| EudraCT/CTIS number | 2008-000623-25 |
| ClinicalTrials.gov number | NCT00745004 |
| Secondary identifying numbers | 6965 |
- 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
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
| Study design | Randomised interventional multicentre treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ondansetron |
| Primary outcome measure | Difference in average stool consistency in the last 2 weeks of treatment of Ondansetron versus placebo |
| Secondary outcome measures | Measured against the primary endpoint in the final 2 weeks of each treatment period: 1. Proportion of patients preferring ondansetron versus placebo 2. Proportion wanting to continue with ondasetron |
| Overall study start date | 01/01/2009 |
| Overall study end date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 150; UK Sample Size: 150 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/01/2009 |
| Recruitment end date | 31/01/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
26/07/2016: Publication reference added.
