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Mesalazine for the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)

NCT01316718 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2014-01-17

No results posted yet for this study

Summary

The purpose of the trial is to define the clinical benefit and possible mediators of the benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.

The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers reflecting mast cell activation and small bowel tone.

Conditions

  • Irritable Bowel Syndrome With Diarrhoea

Interventions

DRUG

Mesalazine

2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

DRUG

Placebo

2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Robin C Spiller, MD · NIHR Biomedical Research Unit, Nottingham University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01316718 on ClinicalTrials.gov