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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Mesalazine cpr 800 mg t.i.d. for 12 weeks |
|
| B | Placebo Comparator | Placebo cpr t.i.d. for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalazine | Drug | Mesalazine 800mg t.i.d. 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| "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 |
| Measure | Description | Time Frame |
|---|---|---|
| "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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Corinaldesi, Professor | Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi | Study Director |
| Barbara Giovanni, Doctor | Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti Torrette | Ancona | Ancona | 60100 | Italy | ||
| Azienda Ospedaliero-Universitaria S.Orsola Malpighi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17241857 | Background | 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. | |
| 15335408 |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Placebo | Drug | Placebo cpr, t.i.d. 12 weeks |
|
| Bologna |
| Bologna |
| 40100 |
| Italy |
| 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 |
| Opera Padre Pio | Foggia | Foggia | 71100 | Italy |
| Azienda Ospedaliera Polo Universitario L.Sacco | Milan | Milano | 20100 | Italy |
| Policlinico S.Donato | San Donato | Milano | 20097 | Italy |
| A.O.U. Policlinico Seconda Università | Naples | Napoli | 80100 | Italy |
| Policlinico | Naples | Napoli | 80100 | Italy |
| U.O. Gastroenterologia Universitaria | Pisa | Pisa | Italy |
| Ospedale S. Maria delle Croci | Ravenna | Ravenna | 48100 | Italy |
| Azienda Ospedaliera San Camillo-Forlanini | Roma | Roma | 00100 | Italy |
| Ospedale Universitario Sant'Andrea | Roma | Roma | 10100 | Italy |
| Università Campus Biomedico | Roma | Roma | 10100 | Italy |
| Ospedale S. Andrea | Vercelli | VC | Italy |
| Ospedale Umberto I Venezia-Mestre | Mestre | Venezia | 30100 | Italy |
| Policlinico G.B. Rossi | Verona | Verona | 37100 | Italy |
| Azienda ULSS 1 | Belluno | Italy |
| Azienda Ospedaliero-Universitaria S. Orsola Malpighi | Bologna | 40100 | Italy |
| Ospedale SS. Annunziata | Chieti | Italy |
| Ospedale Careggi | Florence | Italy |
| Fondazione IRCCS Policlinico | Milan | Italy |
| 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. |
| 14988823 | Background | 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. |
| 12077063 | Background | 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. |
| 25533646 | Derived | 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. |
| D004066 | Digestive System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |