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

SOFAR SPA0 sitesNovember 9, 2007

DrugsPENTACOL 800

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: SOFAR SPA
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 9, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

SOFAR SPA

Eligibility Criteria

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