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A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborator:
St. Orsola Hospital
Information provided by:
SOFAR S.p.A.
ClinicalTrials.gov Identifier:
NCT00774007
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 low grade colonic inflammation.


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: mesalazine
Drug: placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Mesalazine on Low Grade Mucosal Inflammation in Irritable Bowel Syndrome. A Pilot Double Blind Placebo Controlled Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by SOFAR S.p.A.:

Primary Outcome Measures:
  • The primary endpoint in the study was to assess the effect of mesalazine treatment on total number of mucosal immune cells in the colonic mucosa of patients with IBS. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of mesalazine on: 1) mucosal immune cell subsets; 2) inflammatory mediator release from mucosal biopsies; 3) symptom relief, as detected by means of visual analogue scales. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: placebo
Active Comparator: Mesalazine
mesalazine 800 mg t.i.d.
 Drug: mesalazine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774007

Locations
Italy
Department of Internal Medicine & Gastroenterology
Bologna, Italy, 40138
Sponsors and Collaborators
SOFAR S.p.A.
St. Orsola Hospital
Investigators
Principal Investigator: Giovanni Barbara, MD University of Bologna
Study Chair: Roberto Corinaldesi, MD University of Bologna
  More Information

No publications provided

Responsible Party: Dr. Giovanni Barbara, Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, ITALY
ClinicalTrials.gov Identifier: NCT00774007     History of Changes
Other Study ID Numbers: IBS-01/03
Study First Received: October 15, 2008
Last Updated: October 15, 2008
Health Authority: Italy: National Institute of Health

Keywords provided by SOFAR S.p.A.:
Irritable bowel syndrome, abdominal pain, abdominal bloating, immune cells, mast cells

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013