A randomised controlled multicenter trial assessing the efficacy and safety of mesalazine therapy in patients with irritable bowel syndrome. - ND

• Conditions: Irritable Bowel syndrome; MedDRA version: 6.1Level: PTClassification code 10023003

• Registration Number: EUCTR2007-003280-41-IT
• Lead Sponsor: SOFAR SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

-IBS patients (both males and females) with positive diagnosis based on Rome III criteria. -18<=age<=56 years -negative outcome of barium enema or left colonoscopy within the previous five years -negative relevant additional screening or consultation whenever appropriate. -patients capable of conforming to the study protocol; -patients who have given their free and informed consent.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-patients with ascertained inflammatory bowel diseases (Crohn's disease, diverticular disease, ulcerative colitis, infectious colitis, ischemic colitis, microscopic colitis, coeliac disease) -patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable) -presence of major abdominal surgeries -ascertained hypersensitivity to the salicylates -patients with history of clinically significant renal (creatinine >= 2.0 mg/dL or >=177 micromoli/L), hepatic (AST or ALT greater than three times the upper limit of normal range), cardiac, metabolic or haematological disease -esophageal, gastric or duodenal ulcer within 30 days prior to randomization -patients with intended or ascertained pregnancy; lactation -patients who become unable to conform to protocol -patients in topic or systemic antibiotic therapy during the last month -patients in current therapy with corticosteroids, immunosuppressant, lactoferrin, antiallergic compounds (e.g. mast cells stabilizers, antihistaminics) -treatment with any investigational drug within the previous 30 days -treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety -recent history or suspicion of alcohol abuse or drug addiction -any severe pathology that can interfere with the treatment or the clinical or strumental tests of the trial -previous participation in this study

Study & Design

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