Ondansetron for the treatment of IBS with diarrhoea (IBS-D): Identifying the responder” - Ondansetron treatment in IBS-D

Phase 1

• Conditions: Irritable Bowel Syndrome with Diarrhoea; MedDRA version: 9.1 Level: LLT Classification code 10060849 Term: Diarrhoea predominant irritable bowel syndrome; MedDRA version: 9.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome

• Registration Number: EUCTR2008-000623-25-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-03
• Study Completion: 2011-06-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify clinical features which will predict response to Ondansetron in clinical practice in patients with IBS symptoms with diarrhoea.;Secondary Objective: To correlate primary outcome measure with: initial stool frequency, consistency, stool patterns, psychometric scores, plasma 5HIAA and platelet H3-paroxetine binding Bmax, rectal biopsy 5HT cell density and 5HT release, SERT promoter polymorphism .;Primary end point(s): The primary outcome measure is the difference in average stool consistency during the last two week period of drug compared to placebo treatment.