Mesalazine Therapy in Patients With Irritable Bowel Syndrome

The purpose of this study is to determine whether Mesalazine is effective in the treatment of the abdominal discomfort or pain of Irritable Bowel Syndrome patients...

Date First Received: February 21, 2008

Last Updated: October 29, 2008

Verified by: SOFAR S.p.A., October 2008

Clinical Trial Phase: Phase 3 | Start Date: December 2007

Overall Status: Recruiting

Estimated Enrollment: 160

Brief Summary

Official Title: “A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.”

Condition Keyword(s):

Intervention(s):

The purpose of this study is to determine whether Mesalazine is effective in the treatment of the abdominal discomfort or pain of Irritable Bowel Syndrome patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Detailed Clinical Trial Description

The present study is a prospective, double blind, randomised, multicenter trial designed to study the efficacy of mesalazine treatment on symptoms of IBS. In a subgroup of patients the efficacy of this treatment will be also assessed on low-grade inflammation. We expect to confirm that mesalazine treatment reduces the number and activation of inflammatory cells in the colonic mucosa of IBS patients, thus providing the rationale for the assessment of this treatment on symptoms of IBS.

Intervention(s) in this Clinical Trial

  • Drug: Mesalazine
    • Mesalazine 800mg t.i.d. 12 weeks
  • Drug: Placebo
    • Placebo cpr, t.i.d. 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
    • Mesalazine cpr 800 mg t.i.d. for 12 weeks
  • Placebo Comparator: B
    • Placebo cpr t.i.d. for 12 weeks

Outcome Measures for this Clinical Trial

Primary Measures

  • "Responder" is the patient who affirmatively answers on at least 50% of the weekly question:"Did you have satisfactory relief of your abdominal discomfort or pain during the last week?".
    • Time Frame: 3 months
      Safety Issue?: Yes

Secondary Measures

  • "Responder" is the patient who affirmatively answers on at least 50% of the weekly question:"Did you have satisfactory relief of your overall IBS symptoms during the last week?". VAS scale IBS-QoL questionnaire and SF-36 questionnaire
    • Time Frame: 3 months
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

  • Any organic or metabolic disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: SOFAR S.p.A.

Overall Clinical Trial Officials and Contacts

Roberto Corinaldesi, Professor Study Director Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi  

Overall Contact: Giovanni Barbara, Doctor 00 39 3355716938 gbarbara@med.unibo.it

Related Publications

References

Barbara G, Wang B, Stanghellini V, de Giorgio R, Cremon C, Di Nardo G, Trevisani M, Campi B, Geppetti P, Tonini M, Bunnett NW, Grundy D, Corinaldesi R. Mast cell-dependent excitation of visceral-nociceptive sensory neurons in irritable bowel syndrome. Gastroenterology. 2007 Jan;132(1):26-37.

Barbara G, De Giorgio R, Stanghellini V, Cremon C, Salvioli B, Corinaldesi R. New pathophysiological mechanisms in irritable bowel syndrome. Aliment Pharmacol Ther. 2004 Jul;20 Suppl 2:1-9. Review.

Barbara G, Stanghellini V, De Giorgio R, Cremon C, Cottrell GS, Santini D, Pasquinelli G, Morselli-Labate AM, Grady EF, Bunnett NW, Collins SM, Corinaldesi R. Activated mast cells in proximity to colonic nerves correlate with abdominal pain in irritable bowel syndrome. Gastroenterology. 2004 Mar;126(3):693-702.

Barbara G, De Giorgio R, Stanghellini V, Cremon C, Corinaldesi R. A role for inflammation in irritable bowel syndrome? Gut. 2002 Jul;51 Suppl 1:i41-4. Review.

Additional Information

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00626288

Study ID Number: IBS

ClinicalTrials.gov Identifier: NCT00626288

Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.