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A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome

NCT00774007 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-10-16

No results posted yet for this study

Summary

Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces low grade colonic inflammation.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

mesalazine

DRUG

placebo

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • SOFAR S.p.A.

    lead INDUSTRY

Principal Investigators

  • Giovanni Barbara, MD · University of Bologna

  • Roberto Corinaldesi, MD · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • Italy

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 NCT00774007 on ClinicalTrials.gov