E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023003 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary end point of the study will be to assess the effect of mesalazine treatment on the weekly abdominal discomfort or pain of IBS patients. |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoints will include: - weekly satisfactory relief of the overall IBS symptoms; - overall satisfaction with treatment at the end of the treatment period; - IBS-QoL questionnaire and SF-36 questionnaire at baseline, at the end of treatment and at the end of follow-up. - Rescue therapy - Patient's diary: 1-weehly abdominal pain/discomfort, bloating and general well-being intensity by means of VAS scale; 2-daily stool frequency and consistency by means of Bristol scale. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-IBS patients (both males and females) with positive diagnosis based on Rome III criteria. -18<=age<=56 years -negative outcome of barium enema or left colonoscopy within the previous five years -negative relevant additional screening or consultation whenever appropriate. -patients capable of conforming to the study protocol; -patients who have given their free and informed consent. |
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E.4 | Principal exclusion criteria |
-patients with ascertained inflammatory bowel diseases (Crohn's disease, diverticular disease, ulcerative colitis, infectious colitis, ischemic colitis, microscopic colitis, coeliac disease) -patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable) -presence of major abdominal surgeries -ascertained hypersensitivity to the salicylates -patients with history of clinically significant renal (creatinine >= 2.0 mg/dL or >=177 micromoli/L), hepatic (AST or ALT greater than three times the upper limit of normal range), cardiac, metabolic or haematological disease -esophageal, gastric or duodenal ulcer within 30 days prior to randomization -patients with intended or ascertained pregnancy; lactation -patients who become unable to conform to protocol -patients in topic or systemic antibiotic therapy during the last month -patients in current therapy with corticosteroids, immunosuppressant, lactoferrin, antiallergic compounds (e.g. mast cells stabilizers, antihistaminics) -treatment with any investigational drug within the previous 30 days -treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety -recent history or suspicion of alcohol abuse or drug addiction -any severe pathology that can interfere with the treatment or the clinical or strumental tests of the trial -previous participation in this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is the assessment of the mesalazine effect on the abdominal discomfort or pain. Primary efficacy will be assessed using a binary scale based on the patients answers to the following weekly question: ''Did you have satisfactory relief of your abdominal discomfort or pain during the last week?''. The patients will be classified as responders if they reported an affirmative answer on at least 50% of weeks over a 3-month period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |