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

This study has been completed.
Information provided by (Responsible Party):
SOFAR S.p.A. Identifier:
First received: February 21, 2008
Last updated: July 25, 2013
Last verified: July 2013
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.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Mesalazine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.

Resource links provided by NLM:

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

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 187
Study Start Date: December 2007
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Mesalazine cpr 800 mg t.i.d. for 12 weeks
Drug: Mesalazine
Mesalazine 800mg t.i.d. 12 weeks
Other Name: Pentacol 800, Sofar
Placebo Comparator: B
Placebo cpr t.i.d. for 12 weeks
Drug: Placebo
Placebo cpr, t.i.d. 12 weeks

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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

  • Any organic or metabolic disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT00626288

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: SOFAR S.p.A. Identifier: NCT00626288     History of Changes
Other Study ID Numbers: IBS 
Study First Received: February 21, 2008
Last Updated: July 25, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by SOFAR S.p.A.:
Mesalazine in Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016