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CompletedNCT00626288IBS-02/07Updated Jul 26, 2013

Mesalazine Therapy in Patients With Irritable Bowel Syndrome

A Phase 3 interventional study of Mesalazine and Placebo in Irritable Bowel Syndrome, sponsored by SOFAR S.p.A.. Completed at 22 sites in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-26.

Sponsored by SOFAR S.p.A. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
187
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Mesalazine in Irritable Bowel Syndrome
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In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 187 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

SOFAR S.p.A. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion criteria

Exclusion Criteria:

  • Any organic or metabolic disease
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
187 participants (actual)

Study arms

  • Experimental
    A

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

    Drug: Mesalazine

  • Placebo comparator
    B

    Placebo cpr t.i.d. for 12 weeks

    Drug: Placebo

Interventions

  • DrugMesalazine

    Mesalazine 800mg t.i.d. 12 weeks

    Also known as: Pentacol 800, Sofar

  • DrugPlacebo

    Placebo cpr, t.i.d. 12 weeks

06

What researchers measure

Primary outcomes

  1. "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 outcomes

  1. "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

07

Study locations

22 sites
  • U.O. Medicina Interna- Osp. S.S.Annunziata
    Cento, Ferrara 44100, Italy
  • Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
    Lagosanto, Ferrara 44023, Italy
  • Policlinico S.Donato
    San Donato, Milano 20097, Italy
  • Ospedale S. Andrea
    Vercelli, VC, Italy
  • Ospedale Umberto I Venezia-Mestre
    Mestre, Venezia 30100, Italy
  • Ospedali Riuniti Torrette
    Ancona, 60100, Italy
  • Azienda ULSS 1
    Belluno, Italy
  • Azienda Ospedaliero-Universitaria S. Orsola Malpighi
    Bologna, 40100, Italy
  • Azienda Ospedaliero-Universitaria S.Orsola Malpighi
    Bologna, 40100, Italy
  • Ospedale SS. Annunziata
    Chieti, Italy
  • Ospedale Careggi
    Firenze, Italy
  • Opera Padre Pio
    Foggia, 71100, Italy
  • Azienda Ospedaliera Polo Universitario L.Sacco
    Milano, 20100, Italy
  • Fondazione IRCCS Policlinico
    Milano, Italy
  • A.O.U. Policlinico Seconda Università
    Napoli, 80100, Italy
  • Policlinico
    Napoli, 80100, Italy
  • U.O. Gastroenterologia Universitaria
    Pisa, Italy
  • Ospedale S. Maria delle Croci
    Ravenna, 48100, Italy
  • Azienda Ospedaliera San Camillo-Forlanini
    Roma, 00100, Italy
  • Ospedale Universitario Sant'Andrea
    Roma, 10100, Italy
  • Università Campus Biomedico
    Roma, 10100, Italy
  • Policlinico G.B. Rossi
    Verona, 37100, Italy
08

References and documents

Publications

  • 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. PubMed 17241857 ↗
  • 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. PubMed 15335408 ↗
  • 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. PubMed 14988823 ↗
  • 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. PubMed 12077063 ↗
  • 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. PubMed 25533646 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00626288
Lead sponsor
SOFAR S.p.A.
Responsible party
Sponsor
First posted
Feb 29, 2008
Start date
Dec 2007
Primary completion
Mar 2012
Completion
Jul 2012
Last update
Jul 26, 2013

Study contacts

Roberto Corinaldesi, Professor
study director · Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Barbara Giovanni, Doctor
principal investigator · Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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