Mesalazine Therapy in Patients With Irritable Bowel Syndrome

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Mesalazine

• Registration Number: NCT00626288
• Lead Sponsor: SOFAR S.p.A.

Brief Summary

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.

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-29
• Primary Completion: 2012-03
• Study Completion: 2012-07
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-25
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria

• Any organic or metabolic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Placebo cpr t.i.d. for 12 weeks
A	Mesalazine	Mesalazine cpr 800 mg t.i.d. for 12 weeks

Primary Outcome Measures

Name	Time	Method
"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

Name	Time	Method
"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

Trial Locations

Locations (22)

Ospedale SS. Annunziata; 🇮🇹 Chieti, Italy

Opera Padre Pio; 🇮🇹 Foggia, Italy

Azienda Ospedaliera Polo Universitario L.Sacco; 🇮🇹 Milano, Italy

Ospedale S. Andrea; 🇮🇹 Vercelli, VC, Italy

Azienda ULSS 1; 🇮🇹 Belluno, Italy

Policlinico G.B. Rossi; 🇮🇹 Verona, Italy

Ospedale Umberto I Venezia-Mestre; 🇮🇹 Mestre, Venezia, Italy

Azienda Ospedaliero-Universitaria S.Orsola Malpighi; 🇮🇹 Bologna, Italy

Ospedale Universitario Sant'Andrea; 🇮🇹 Roma, Italy

Policlinico S.Donato; 🇮🇹 San Donato, Milano, Italy

Fondazione IRCCS Policlinico; 🇮🇹 Milano, Italy

Policlinico; 🇮🇹 Napoli, Italy

Azienda Ospedaliera San Camillo-Forlanini; 🇮🇹 Roma, Italy

Ospedali Riuniti Torrette; 🇮🇹 Ancona, Italy

Ospedale Careggi; 🇮🇹 Firenze, Italy

Azienda Ospedaliero-Universitaria S. Orsola Malpighi; 🇮🇹 Bologna, Italy

U.O. Gastroenterologia Universitaria; 🇮🇹 Pisa, Italy

Ospedale S. Maria delle Croci; 🇮🇹 Ravenna, Italy

A.O.U. Policlinico Seconda Università; 🇮🇹 Napoli, Italy

Università Campus Biomedico; 🇮🇹 Roma, Italy

Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta; 🇮🇹 Lagosanto, Ferrara, Italy

U.O. Medicina Interna- Osp. S.S.Annunziata; 🇮🇹 Cento, Ferrara, Italy