Mesalazine Therapy in Patients With Irritable Bowel Syndrome (IBS-02/07)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by SOFAR S.p.A..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
SOFAR S.p.A.
Information provided by (Responsible Party):
SOFAR S.p.A.
ClinicalTrials.gov Identifier:
NCT00626288
First received: February 21, 2008
Last updated: March 12, 2012
Last verified: October 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome |
Drug: Mesalazine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
Resource links provided by NLM:
Further study details as provided by SOFAR S.p.A.:
Primary Outcome Measures:
- "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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- "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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 187 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- IBS patients with positive diagnosis inclosing Rome III criteria
Exclusion Criteria:
- Any organic or metabolic disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 | |
| Fondazione IRCCS Policlinico | |
| Milano, Italy | |
| Azienda Ospedaliera Polo Universitario L.Sacco | |
| Milano, Italy, 20100 | |
| Policlinico | |
| Napoli, Italy, 80100 | |
| A.O.U. Policlinico Seconda Università | |
| 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 | |
| Università Campus Biomedico | |
| Roma, Italy, 10100 | |
| Ospedale Universitario Sant'Andrea | |
| 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 |
More Information
Publications:
| Responsible Party: | SOFAR S.p.A. |
| ClinicalTrials.gov Identifier: | NCT00626288 History of Changes |
| Other Study ID Numbers: | IBS |
| Study First Received: | February 21, 2008 |
| Last Updated: | March 12, 2012 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by SOFAR S.p.A.:
|
Mesalazine in Irritable Bowel Syndrome |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome 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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013