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

NCT00774007 | Completed Phase 2 DMC

• 1 other identifier: IBS-01/03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 low grade colonic inflammation.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome, abdominal pain, abdominal bloating, immune cells, mast cells

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• 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.

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Mesalazine

ACTIVE COMPARATOR

mesalazine 800 mg t.i.d.

Drug: mesalazine

Interventions

mesalazine DRUG

Mesalazine

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SOFAR S.p.A.: lead
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (1)

Department of Internal Medicine & Gastroenterology

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Giovanni Barbara, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

• Roberto Corinaldesi, MD

  University of Bologna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: September 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: October 16, 2008

Record last verified: 2008-10

Locations

IT (1)