Mesalazine Therapy in Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— IBS-02/07  

Official title:

A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626288
• Other study ID #: IBS
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2008
• Last updated: July 25, 2013
• Start date: December 2007
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: SOFAR S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

• Any organic or metabolic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Mesalazine
Mesalazine 800mg t.i.d. 12 weeks
• Placebo
Placebo cpr, t.i.d. 12 weeks

Locations

Country	Name	City	State
Italy	Ospedali Riuniti Torrette	Ancona
Italy	Azienda ULSS 1	Belluno
Italy	Azienda Ospedaliero-Universitaria S. Orsola Malpighi	Bologna
Italy	Azienda Ospedaliero-Universitaria S.Orsola Malpighi	Bologna
Italy	U.O. Medicina Interna- Osp. S.S.Annunziata	Cento	Ferrara
Italy	Ospedale SS. Annunziata	Chieti
Italy	Ospedale Careggi	Firenze
Italy	Opera Padre Pio	Foggia
Italy	Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta	Lagosanto	Ferrara
Italy	Ospedale Umberto I Venezia-Mestre	Mestre	Venezia
Italy	Azienda Ospedaliera Polo Universitario L.Sacco	Milano
Italy	Fondazione IRCCS Policlinico	Milano
Italy	A.O.U. Policlinico Seconda Università	Napoli
Italy	Policlinico	Napoli
Italy	U.O. Gastroenterologia Universitaria	Pisa
Italy	Ospedale S. Maria delle Croci	Ravenna
Italy	Azienda Ospedaliera San Camillo-Forlanini	Roma
Italy	Ospedale Universitario Sant'Andrea	Roma
Italy	Università Campus Biomedico	Roma
Italy	Policlinico S.Donato	San Donato	Milano
Italy	Ospedale S. Andrea	Vercelli	VC
Italy	Policlinico G.B. Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
SOFAR S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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:i41-4. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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	Yes
Secondary	"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	Yes