Mesalazine Therapy in Patients With Irritable Bowel Syndrome
NCT ID: NCT00626288
Last Updated: 2013-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
187 participants
INTERVENTIONAL
2007-12-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Mesalazine cpr 800 mg t.i.d. for 12 weeks
Mesalazine
Mesalazine 800mg t.i.d. 12 weeks
B
Placebo cpr t.i.d. for 12 weeks
Placebo
Placebo cpr, t.i.d. 12 weeks
Interventions
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Mesalazine
Mesalazine 800mg t.i.d. 12 weeks
Placebo
Placebo cpr, t.i.d. 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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SOFAR S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Roberto Corinaldesi, Professor
Role: STUDY_DIRECTOR
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Barbara Giovanni, Doctor
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Locations
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Ospedali Riuniti Torrette
Ancona, Ancona, Italy
Azienda Ospedaliero-Universitaria S.Orsola Malpighi
Bologna, Bologna, Italy
U.O. Medicina Interna- Osp. S.S.Annunziata
Cento, Ferrara, Italy
Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
Lagosanto, Ferrara, Italy
Opera Padre Pio
Foggia, Foggia, Italy
Azienda Ospedaliera Polo Universitario L.Sacco
Milan, Milano, Italy
Policlinico S.Donato
San Donato, Milano, Italy
A.O.U. Policlinico Seconda Università
Napoli, Napoli, Italy
Policlinico
Napoli, Napoli, Italy
U.O. Gastroenterologia Universitaria
Pisa, Pisa, Italy
Ospedale S. Maria delle Croci
Ravenna, Ravenna, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, Roma, Italy
Ospedale Universitario Sant'Andrea
Roma, Roma, Italy
Università Campus Biomedico
Roma, Roma, Italy
Ospedale S. Andrea
Vercelli, VC, Italy
Ospedale Umberto I Venezia-Mestre
Mestre, Venezia, Italy
Policlinico G.B. Rossi
Verona, Verona, Italy
Azienda ULSS 1
Belluno, , Italy
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
Bologna, , Italy
Ospedale SS. Annunziata
Chieti, , Italy
Ospedale Careggi
Florence, , Italy
Fondazione IRCCS Policlinico
Milan, , Italy
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IBS
Identifier Type: -
Identifier Source: org_study_id
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