Condition category
Digestive System
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
26/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Klara Garsed

ORCID ID

Contact details

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

2008-000623-25

ClinicalTrials.gov number

NCT00745004

Protocol/serial number

6965

Study information

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)

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

Nottingham Research Ethics Committee 2, 10/11/2008, ref: 08/H0408/134

Study design

Randomised interventional multicentre treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Ondansetron

Primary outcome measures

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 trial start date

01/01/2009

Overall trial end date

31/01/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150

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

United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24334242

Publication citations

Additional files

Editorial Notes

26/07/2016: Publication reference added.