Irritable Bowel syndrome MedDRA version: 6.1 Level: PT Classification code 10023003
Conditions
Interventions
Trade Name: PENTACOL 800
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
SOFAR SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -IBS patients (both males and females) with positive diagnosis based on Rome III criteria. -18=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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. | — |
Countries
Italy
Outcome results
None listed