Evaluation of the role of mesalazine in the treatment of diverticular disease of the colon and irritable colon syndrome: A randomised double blind placebo controlled clinical study - ND

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10009993; Irritable bowel Syndrome Diverticular disease of the colon; MedDRA version: 9.1Level: LLTClassification code 10023004

• Registration Number: EUCTR2008-004228-22-IT
• Lead Sponsor: SOFAR SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- males and females age > 45 years -first endoscopic and clinic diagnosis of symptomatic, uncomplicated diverticular disease of the colon OR - first endoscopic and clinic diagnosis of Irritable Bowel Syndrome -written consent -ability to understand all the study procedures
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

-previous therapy for diverticular disease or IBS -rectal bleeding -regular assuntion of cardioaspirin,NSAID, antibiotisc, probiotics, cortison-based drugs in the previuous month -allergy to salicilates -pregnancy or lactation -IBD`s -acute diverticulitis -impossibility to give a written consent or to understand all the protocol rules

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: - to evaluate the efficacy of mesalazine in the improvement of the clinical condition of the two study disease. - to evaluate the role of mesalazine in the modification of the histologic pattern of the colonic mucosa.;Secondary Objective: - to evaluate the importance of flogosis in the pathogenesis and clinc of diverticular disease of the colon and of the irritable bowel syndrome - correlation between the histologic evidence and symptoms after the study treatment taking.;Primary end point(s): improvement of the symptoms of the two study diseases.