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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00745004
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : January 24, 2012
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Diarrhoea Drug: Ondansetron Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D): Identifying the "Responder"
Study Start Date : January 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745004


Locations
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United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M23 9LT
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Robin Spiller University of Nottingham
Principal Investigator: Peter Whorwell, MD Manchester University NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT00745004    
Other Study ID Numbers: 08027
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012
Keywords provided by University of Nottingham:
IBS D
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Diarrhea
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents