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

Sponsor:	University of Nottingham
Collaborator:	National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):	University of Nottingham
ClinicalTrials.gov Identifier:	NCT00745004

Purpose

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	Intervention	Phase
Irritable Bowel Syndrome With Diarrhoea	Drug: Ondansetron Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D): Identifying the "Responder"

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by University of Nottingham:

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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: Duration of study and post-study analysis ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	January 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745004

Locations

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

Principal Investigator:	Robin Spiller	University of Nottingham
Principal Investigator:	Peter Whorwell, MD	University Hospital of South Manchester NHS Foundation Trust

More Information

No publications provided

Responsible Party:	University of Nottingham
ClinicalTrials.gov Identifier:	NCT00745004 History of Changes
Other Study ID Numbers:	08027
Study First Received:	August 29, 2008
Last Updated:	January 23, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; United Kingdom: National Health Service

Keywords provided by University of Nottingham:

IBS D

Additional relevant MeSH terms:

Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on February 09, 2012