Mesalazine Therapy in Patients With Irritable Bowel Syndrome
IBS-02/07
A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.
1 other identifier
interventional
187
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2007
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 26, 2013
July 1, 2013
4.3 years
February 21, 2008
July 25, 2013
Conditions
Keywords
Outcome Measures
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?".
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
3 months
Study Arms (2)
A
EXPERIMENTALMesalazine cpr 800 mg t.i.d. for 12 weeks
B
PLACEBO COMPARATORPlacebo cpr t.i.d. for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- IBS patients with positive diagnosis inclosing Rome III criteria
You may not qualify if:
- Any organic or metabolic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SOFAR S.p.A.lead
Study Sites (22)
Ospedali Riuniti Torrette
Ancona, Ancona, 60100, Italy
Azienda Ospedaliero-Universitaria S.Orsola Malpighi
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
Napoli, Napoli, 80100, Italy
Policlinico
Napoli, 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
Related Publications (5)
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.
PMID: 17241857BACKGROUNDBarbara 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.
PMID: 15335408BACKGROUNDBarbara 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.
PMID: 14988823BACKGROUNDBarbara 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.
PMID: 12077063BACKGROUNDBarbara 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.
PMID: 25533646DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roberto Corinaldesi, Professor
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
- PRINCIPAL INVESTIGATOR
Barbara Giovanni, Doctor
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2008
First Posted
February 29, 2008
Study Start
December 1, 2007
Primary Completion
March 1, 2012
Study Completion
July 1, 2012
Last Updated
July 26, 2013
Record last verified: 2013-07