Mesalazine Therapy in Patients With Irritable Bowel Syndrome (IBS-02/07)

A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of 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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Mesalazine; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy, 60100
    • Ospedali Riuniti Torrette
  • Belluno, Italy
    • Azienda ULSS 1
  • Bologna, Italy, 40100
    • Azienda Ospedaliero-Universitaria S. Orsola Malpighi
  • Bologna, Italy, 40100
    • Azienda Ospedaliero-Universitaria S.Orsola Malpighi
  • Chieti, Italy
    • Ospedale SS. Annunziata
  • Firenze, Italy
    • Ospedale Careggi
  • Foggia, Italy, 71100
    • Opera Padre Pio
  • Milano, Italy, 20100
    • Azienda Ospedaliera Polo Universitario L.Sacco
  • Milano, Italy
    • Fondazione IRCCS Policlinico
  • Napoli, Italy, 80100
    • A.O.U. Policlinico Seconda Università
  • Napoli, Italy, 80100
    • Policlinico
  • Pisa, Italy
    • U.O. Gastroenterologia Universitaria
  • Ravenna, Italy, 48100
    • Ospedale S. Maria Delle Croci
  • Roma, Italy, 00100
    • Azienda Ospedaliera San Camillo-Forlanini
  • Roma, Italy, 10100
    • Ospedale Universitario Sant'Andrea
  • Roma, Italy, 10100
    • Università Campus Biomedico
  • Verona, Italy, 37100
    • Policlinico G.B. Rossi
  • Ferrara
    • Cento, Ferrara, Italy, 44100
      • U.O. Medicina Interna- Osp. S.S.Annunziata
    • Lagosanto, Ferrara, Italy, 44023
      • Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
  • Milano
    • San Donato, Milano, Italy, 20097
      • Policlinico S.Donato
  • VC
    • Vercelli, VC, Italy
      • Ospedale S. Andrea
  • Venezia
    • Mestre, Venezia, Italy, 30100
      • Ospedale Umberto I Venezia-Mestre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

• Any organic or metabolic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Mesalazine cpr 800 mg t.i.d. for 12 weeks	Drug: Mesalazine; Mesalazine 800mg t.i.d. 12 weeks; Other Names: Pentacol 800, Sofar
Placebo Comparator: B; Placebo cpr t.i.d. for 12 weeks	Drug: Placebo; Placebo cpr, t.i.d. 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
"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?".	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
"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	3 months

Collaborators and Investigators

• Sponsor: SOFAR S.p.A.
• Investigators: Study Director: Roberto Corinaldesi, Professor, Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi; Principal Investigator: Barbara Giovanni, Doctor, Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi

Publications and helpful links

General Publications

• 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. doi: 10.1053/j.gastro.2006.11.039.
• 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. doi: 10.1111/j.1365-2036.2004.02036.x.
• 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. doi: 10.1053/j.gastro.2003.11.055.
• 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(Suppl 1):i41-4. doi: 10.1136/gut.51.suppl_1.i41.
• Barbara G, Cremon C, Annese V, Basilisco G, Bazzoli F, Bellini M, Benedetti A, Benini L, Bossa F, Buldrini P, Cicala M, Cuomo R, Germana B, Molteni P, Neri M, Rodi M, Saggioro A, Scribano ML, Vecchi M, Zoli G, Corinaldesi R, Stanghellini V. Randomised controlled trial of mesalazine in IBS. Gut. 2016 Jan;65(1):82-90. doi: 10.1136/gutjnl-2014-308188. Epub 2014 Dec 22.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: February 21, 2008
• First Submitted That Met QC Criteria: February 21, 2008
• First Posted (Estimate): February 29, 2008

Study Record Updates

• Last Update Posted (Estimate): July 26, 2013
• Last Update Submitted That Met QC Criteria: July 25, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Mesalazine in Irritable Bowel Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: IBS