- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626288
Mesalazine Therapy in Patients With Irritable Bowel Syndrome (IBS-02/07)
July 25, 2013 updated by: SOFAR S.p.A.
A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
187
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ancona, Italy, 60100
- Ospedali Riuniti Torrette
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Belluno, Italy
- Azienda ULSS 1
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Bologna, Italy, 40100
- Azienda Ospedaliero-Universitaria S. Orsola Malpighi
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Bologna, Italy, 40100
- Azienda Ospedaliero-Universitaria S.Orsola Malpighi
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Chieti, Italy
- Ospedale Ss. Annunziata
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Firenze, Italy
- Ospedale Careggi
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Foggia, Italy, 71100
- Opera Padre Pio
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Milano, Italy, 20100
- Azienda Ospedaliera Polo Universitario L.Sacco
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Milano, Italy
- Fondazione IRCCS Policlinico
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Napoli, Italy, 80100
- A.O.U. Policlinico Seconda Università
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Napoli, Italy, 80100
- Policlinico
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Pisa, Italy
- U.O. Gastroenterologia Universitaria
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Ravenna, Italy, 48100
- Ospedale S. Maria Delle Croci
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Roma, Italy, 00100
- Azienda Ospedaliera San Camillo-Forlanini
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Roma, Italy, 10100
- Ospedale Universitario Sant'Andrea
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Roma, Italy, 10100
- Università Campus Biomedico
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Verona, Italy, 37100
- Policlinico G.B. Rossi
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Ferrara
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Cento, Ferrara, Italy, 44100
- U.O. Medicina Interna- Osp. S.S.Annunziata
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Lagosanto, Ferrara, Italy, 44023
- Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
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Milano
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San Donato, Milano, Italy, 20097
- Policlinico S.Donato
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VC
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Vercelli, VC, Italy
- Ospedale S. Andrea
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Venezia
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Mestre, Venezia, Italy, 30100
- Ospedale Umberto I Venezia-Mestre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IBS patients with positive diagnosis inclosing Rome III criteria
Exclusion Criteria:
- Any organic or metabolic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Mesalazine cpr 800 mg t.i.d. for 12 weeks
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Mesalazine 800mg t.i.d. 12 weeks
Other Names:
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Placebo Comparator: B
Placebo cpr t.i.d. for 12 weeks
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Placebo cpr, t.i.d. 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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?".
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 21, 2008
First Submitted That Met QC Criteria
February 21, 2008
First Posted (Estimate)
February 29, 2008
Study Record Updates
Last Update Posted (Estimate)
July 26, 2013
Last Update Submitted That Met QC Criteria
July 25, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Mesalamine
Other Study ID Numbers
- IBS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
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Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
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