NCT00626288

Mesalazine Therapy in Patients With Irritable Bowel Syndrome

A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: SOFAR S.p.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Mesalazine is effective in the treatment of the abdominal discomfort or pain of Irritable Bowel Syndrome patients.

Detailed description

The present study is a prospective, double blind, randomised, multicenter trial designed to study the efficacy of mesalazine treatment on symptoms of IBS. In a subgroup of patients the efficacy of this treatment will be also assessed on low-grade inflammation. We expect to confirm that mesalazine treatment reduces the number and activation of inflammatory cells in the colonic mucosa of IBS patients, thus providing the rationale for the assessment of this treatment on symptoms of IBS.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Mesalazine	Mesalazine 800mg t.i.d. 12 weeks
DRUG	Placebo	Placebo cpr, t.i.d. 12 weeks

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2008-02-29
• Last updated: 2013-07-26

Locations

22 sites across 1 country: Italy