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

Primary Purpose

Irritable Bowel Syndrome With Diarrhoea

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Ondansetron
Placebo
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhoea focused on measuring IBS D

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of South Manchester NHS Foundation Trust
  • University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days.

Placebo 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days.

Outcomes

Primary Outcome Measures

The primary outcome measure is the difference in average stool consistency during the last two week period of Ondansetron compared to placebo treatment.

Secondary Outcome Measures

1) Proportion of patients preferring ondansetron versus placebo 2) Proportion wanting to continue with ondansetron versus placebo 3) Difference between ondansetron and placebo periods.

Full Information

First Posted
August 29, 2008
Last Updated
January 23, 2012
Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00745004
Brief Title
Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)
Official Title
Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D): Identifying the "Responder"
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhoea
Keywords
IBS D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Spiller
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Whorwell, MD
Organizational Affiliation
Manchester University NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of South Manchester NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23911555
Citation
Tooth D, Garsed K, Singh G, Marciani L, Lam C, Fordham I, Fields A, Banwait R, Lingaya M, Layfield R, Hastings M, Whorwell P, Spiller R. Characterisation of faecal protease activity in irritable bowel syndrome with diarrhoea: origin and effect of gut transit. Gut. 2014 May;63(5):753-60. doi: 10.1136/gutjnl-2012-304042. Epub 2013 Aug 2.
Results Reference
derived

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

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