Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)

January 23, 2012 updated by: University of Nottingham

Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D): Identifying the "Responder"

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 Nottingham have suggested that some patients with diarrhoea may have an excess of a chemical called serotonin in their gut. Serotonin stimulates secretion and propulsion in the gut and contributes to diarrhoea. We are interested to see whether a drug, Ondansetron, which blocks the effect of serotonin, would improve symptoms in patients with IBS and diarrhoea. We think the drug may work better in people with a specific gene type so your genetic makeup may be of influence and we would like to test this. Because IBS symptoms fluctuate, one way to determine whether Ondansetron is effective is to perform a randomised placebo controlled trial in which neither the patient nor the doctor knows which medication is being taken in each part of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M23 9LT
        • University Hospital of South Manchester NHS Foundation Trust
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days.
Drug: Ondansetron
Over-encapsulated 4mg ondansetron tablets. Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days. For 5 weeks.
Placebo Comparator: 2
Placebo 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days.
Drug: Placebo
Capsule matching over-encapsulated experimental drug. 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days. For 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is the difference in average stool consistency during the last two week period of Ondansetron compared to placebo treatment.
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
1) Proportion of patients preferring ondansetron versus placebo 2) Proportion wanting to continue with ondansetron versus placebo 3) Difference between ondansetron and placebo periods.
Time Frame: Duration of study and post-study analysis
Duration of study and post-study analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Peter Whorwell, MD, Manchester University NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 23, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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