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Mesalazine Therapy in Patients With Irritable Bowel Syndrome (IBS-02/07)

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ClinicalTrials.gov Identifier: NCT00626288
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : July 26, 2013
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Mesalazine Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.
Study Start Date : December 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
Mesalazine cpr 800 mg t.i.d. for 12 weeks
Drug: Mesalazine
Mesalazine 800mg t.i.d. 12 weeks
Other Name: Pentacol 800, Sofar

Placebo Comparator: B
Placebo cpr t.i.d. for 12 weeks
Drug: Placebo
Placebo cpr, t.i.d. 12 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

  • Any organic or metabolic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626288


Locations
Italy
U.O. Medicina Interna- Osp. S.S.Annunziata
Cento, Ferrara, Italy, 44100
Azienda Sanitaria Unità Locale di Ferrara- Ospedale del Delta
Lagosanto, Ferrara, Italy, 44023
Policlinico S.Donato
San Donato, Milano, Italy, 20097
Ospedale S. Andrea
Vercelli, VC, Italy
Ospedale Umberto I Venezia-Mestre
Mestre, Venezia, Italy, 30100
Ospedali Riuniti Torrette
Ancona, Italy, 60100
Azienda ULSS 1
Belluno, Italy
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
Bologna, Italy, 40100
Azienda Ospedaliero-Universitaria S.Orsola Malpighi
Bologna, Italy, 40100
Ospedale SS. Annunziata
Chieti, Italy
Ospedale Careggi
Firenze, Italy
Opera Padre Pio
Foggia, Italy, 71100
Azienda Ospedaliera Polo Universitario L.Sacco
Milano, Italy, 20100
Fondazione IRCCS Policlinico
Milano, Italy
A.O.U. Policlinico Seconda Università
Napoli, Italy, 80100
Policlinico
Napoli, Italy, 80100
U.O. Gastroenterologia Universitaria
Pisa, Italy
Ospedale S. Maria delle Croci
Ravenna, Italy, 48100
Azienda Ospedaliera San Camillo-Forlanini
Roma, Italy, 00100
Ospedale Universitario Sant'Andrea
Roma, Italy, 10100
Università Campus Biomedico
Roma, Italy, 10100
Policlinico G.B. Rossi
Verona, Italy, 37100
Sponsors and Collaborators
SOFAR S.p.A.
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov Identifier: NCT00626288     History of Changes
Other Study ID Numbers: IBS
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013

Keywords provided by SOFAR S.p.A.:
Mesalazine in Irritable Bowel Syndrome

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents