Clinical trial NCT00626288: Mesalazine Therapy in Patients With Irritable Bowel Syndrome
Official title: A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Mesalazine in Irritable Bowel Syndrome
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

* Any organic or metabolic disease

Primary outcomes:
measure: "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?".
timeFrame: 3 months
Secondary outcomes:
measure: "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
timeFrame: 3 months
Other outcomes:
Locations:
city: Cento
country: Italy
facility: U.O. Medicina Interna- Osp. S.S.Annunziata
state: Ferrara
city: Lagosanto
country: Italy
facility: Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
state: Ferrara
city: San Donato
country: Italy
facility: Policlinico S.Donato
state: Milano
city: Vercelli
country: Italy
facility: Ospedale S. Andrea
state: VC
city: Mestre
country: Italy
facility: Ospedale Umberto I Venezia-Mestre
state: Venezia
city: Ancona
country: Italy
facility: Ospedali Riuniti Torrette
city: Belluno
country: Italy
facility: Azienda ULSS 1
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S. Orsola Malpighi
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola Malpighi
city: Chieti
country: Italy
facility: Ospedale SS. Annunziata
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Foggia
country: Italy
facility: Opera Padre Pio
city: Milano
country: Italy
facility: Azienda Ospedaliera Polo Universitario L.Sacco
city: Milano
country: Italy
facility: Fondazione IRCCS Policlinico
city: Napoli
country: Italy
facility: A.O.U. Policlinico Seconda Università
city: Napoli
country: Italy
facility: Policlinico
city: Pisa
country: Italy
facility: U.O. Gastroenterologia Universitaria
city: Ravenna
country: Italy
facility: Ospedale S. Maria delle Croci
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo-Forlanini
city: Roma
country: Italy
facility: Ospedale Universitario Sant'Andrea
city: Roma
country: Italy
facility: Università Campus Biomedico
city: Verona
country: Italy
facility: Policlinico G.B. Rossi
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
name: Roberto Corinaldesi, Professor
role: STUDY_DIRECTOR
affiliation: Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
name: Barbara Giovanni, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.