Clinical Trial: Mesalazine Therapy in Patients With Irritable Bowel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: SOFAR S.p.A.

Current Primary Outcome: "Responder" is the patient who affirmatively answers on at least 50% of the weekly question:"Did you have satisfactory relief of your abdominal discomfort or pain during the last week?". [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: "Responder" is the patient who affirmatively answers on at least 50% of the weekly question:"Did you have satisfactory relief of your overall IBS symptoms during the last week?". VAS scale IBS-QoL questionnaire and SF-36 questionnaire [ Time Frame: 3 months ]

Original Secondary Outcome: Same as current

Information By: SOFAR S.p.A.

Dates:
Date Received: February 21, 2008
Date Started: December 2007
Date Completion:
Last Updated: July 25, 2013
Last Verified: July 2013