Status:
COMPLETED
A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome
Lead Sponsor:
SOFAR S.p.A.
Collaborating Sponsors:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces...
Detailed Description
Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces...
Eligibility Criteria
Inclusion
- IBS patients (both males and females) with positive diagnosis based on Rome II criteria
- age ≥ 18 years
- Patients capable of conforming to the study protocol;
- Patients who have given their free and informed consent
Exclusion
- Patients with ascertained Inflammatory Bowel Diseases (Crohn disease, Diverticular disease, Ulcerative colitis, Infectious colitis, Ischemic colitis, microscopic colitis)
- Patients with ascertained food intolerance/allergy
- 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
- Positive faecal culture for bacterial, or parasitic pathogens
- Patients with history of clinically significant renal (creatinine ≥ 2.0 mg/dL or ≥177 μmol/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 who are continuously taking laxatives
- Patients in antibiotic therapy during the last month
- Patients in current therapy with corticosteroids
- 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 tests of the trial
- Previous participation in this study
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00774007
Start Date
September 1 2004
End Date
November 1 2005
Last Update
October 16 2008
Active Locations (1)
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1
Department of Internal Medicine & Gastroenterology
Bologna, Italy, 40138