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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.
ClinicalTrials.gov Identifier:
NCT00626288
First received: February 21, 2008
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.

  Eligibility

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

Inclusion Criteria:

  • IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

  • Any organic or metabolic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626288

Locations
Italy
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
Policlinico
Napoli, Italy, 80100
A.O.U. Policlinico Seconda Università
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
Università Campus Biomedico
Roma, Italy, 10100
Ospedale Universitario Sant'Andrea
Roma, Italy, 10100
Policlinico G.B. Rossi
Verona, Italy, 37100
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov 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:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
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 September 18, 2014