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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Mesalazine
Placebo
Sponsored by
SOFAR S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Mesalazine in Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

  • Any organic or metabolic disease

Sites / Locations

  • U.O. Medicina Interna- Osp. S.S.Annunziata
  • Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
  • Policlinico S.Donato
  • Ospedale S. Andrea
  • Ospedale Umberto I Venezia-Mestre
  • Ospedali Riuniti Torrette
  • Azienda ULSS 1
  • Azienda Ospedaliero-Universitaria S. Orsola Malpighi
  • Azienda Ospedaliero-Universitaria S.Orsola Malpighi
  • Ospedale SS. Annunziata
  • Ospedale Careggi
  • Opera Padre Pio
  • Azienda Ospedaliera Polo Universitario L.Sacco
  • Fondazione IRCCS Policlinico
  • A.O.U. Policlinico Seconda Università
  • Policlinico
  • U.O. Gastroenterologia Universitaria
  • Ospedale S. Maria delle Croci
  • Azienda Ospedaliera San Camillo-Forlanini
  • Ospedale Universitario Sant'Andrea
  • Università Campus Biomedico
  • Policlinico G.B. Rossi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Mesalazine cpr 800 mg t.i.d. for 12 weeks

Placebo cpr t.i.d. for 12 weeks

Outcomes

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?".

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

Full Information

First Posted
February 21, 2008
Last Updated
July 25, 2013
Sponsor
SOFAR S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00626288
Brief Title
Mesalazine Therapy in Patients With Irritable Bowel Syndrome
Acronym
IBS-02/07
Official Title
A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOFAR S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Mesalazine in Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Mesalazine cpr 800 mg t.i.d. for 12 weeks
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo cpr t.i.d. for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Other Intervention Name(s)
Pentacol 800, Sofar
Intervention Description
Mesalazine 800mg t.i.d. 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo cpr, t.i.d. 12 weeks
Primary Outcome Measure Information:
Title
"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
Secondary Outcome Measure Information:
Title
"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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IBS patients with positive diagnosis inclosing Rome III criteria Exclusion Criteria: Any organic or metabolic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Corinaldesi, Professor
Organizational Affiliation
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Barbara Giovanni, Doctor
Organizational Affiliation
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O. Medicina Interna- Osp. S.S.Annunziata
City
Cento
State/Province
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
City
Lagosanto
State/Province
Ferrara
ZIP/Postal Code
44023
Country
Italy
Facility Name
Policlinico S.Donato
City
San Donato
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Ospedale S. Andrea
City
Vercelli
State/Province
VC
Country
Italy
Facility Name
Ospedale Umberto I Venezia-Mestre
City
Mestre
State/Province
Venezia
ZIP/Postal Code
30100
Country
Italy
Facility Name
Ospedali Riuniti Torrette
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Azienda ULSS 1
City
Belluno
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola Malpighi
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
Ospedale SS. Annunziata
City
Chieti
Country
Italy
Facility Name
Ospedale Careggi
City
Firenze
Country
Italy
Facility Name
Opera Padre Pio
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Azienda Ospedaliera Polo Universitario L.Sacco
City
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
Fondazione IRCCS Policlinico
City
Milano
Country
Italy
Facility Name
A.O.U. Policlinico Seconda Università
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
Policlinico
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
U.O. Gastroenterologia Universitaria
City
Pisa
Country
Italy
Facility Name
Ospedale S. Maria delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo-Forlanini
City
Roma
ZIP/Postal Code
00100
Country
Italy
Facility Name
Ospedale Universitario Sant'Andrea
City
Roma
ZIP/Postal Code
10100
Country
Italy
Facility Name
Università Campus Biomedico
City
Roma
ZIP/Postal Code
10100
Country
Italy
Facility Name
Policlinico G.B. Rossi
City
Verona
ZIP/Postal Code
37100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17241857
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.
Results Reference
background
PubMed Identifier
15335408
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.
Results Reference
background
PubMed Identifier
14988823
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.
Results Reference
background
PubMed Identifier
12077063
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.
Results Reference
background
PubMed Identifier
25533646
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.
Results Reference
derived

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Mesalazine Therapy in Patients With Irritable Bowel Syndrome

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