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

NCT00745004 | Completed Phase 4

• 1 other identifier: 08027
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Irritable Bowel Syndrome With Diarrhoea

Keywords

IBS D

Outcome Measures

Primary Outcomes (1)

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

  2 weeks

Secondary Outcomes (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.

  Duration of study and post-study analysis

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Ondansetron

2

PLACEBO COMPARATOR

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

Interventions

Ondansetron DRUG

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.

1

Placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant or breastfeeding
• Patients that, in the opinion of the investigator, are considered unsuitable.
• 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

Sponsors & Collaborators

• University of Nottingham: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

University Hospital of South Manchester NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23911555 DERIVED

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Robin Spiller

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Peter Whorwell, MD

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

GB (2)