Irritable Bowel Syndrome MedDRA version: 14.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Asacol
Pharmaceutical Form: Tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 18 to 70 years, both inclusive 2) Subject is diagnosed with irritable bowel syndrome (IBS) prior to Screening based on the Rome III diagnostic criteria for IBS 3) Subject presents with IBS symptom intensity of at least moderate level; defined as an IBS Severity Scoring System (IBS-SSS) score of =175 at both Screening and Baseline 4) Provision of signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1) Subjects who are unable to understand the written and verbal instructions 2) Presence of a systemic inflammatory disease 3) Presence of other gastrointestinal diseases likely to explain the IBS symptoms 4) Presence of other severe somatic disease 5) Treatment with non-steroidal anti-inflammatory drugs (NSAID), opioid analgetics or acetylsalicylic acid (ASA) compounds within 7 days prior to Screening 6) Treatment with systemic antibiotics within 28 days prior to Screening 7) Treatment with immunosuppressant drugs within 28 days prior to Screening 8) Other significant medical treatment, which, in the opinion of the investigator, may compromise the safety and efficacy objectives of the study, within 28 days prior to Screening 9) Previously confirmed allergy towards ASA or mesalazine 10) Presence of renal disease and/or concomitant treatment with medications with potential renal side effects 11) Current ongoing infection 11) History of, or current, drug or alcohol dependence 12) Pregnant or lactating women 13) Subjects suspected not to follow instructions based on the discretion of the Investigator 14) Current participation in other intervention studies 15) Female subjects of childbearing potential unwilling to use adequate contraceptive measures throughout the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of mesalazine (Asacol®) treatment compared to placebo on IBS symptoms.;Secondary Objective: To assess mesalazine (Asacol®) treatment compared to placebo regarding: 1)Inflammatory mediators measured by the Mucosal Patch Technology 2)Effects on immune cells and cytokines in mucosal biopsies 3)Calprotectin levels in faeces 4)Individual IBS symptom parameters;Primary end point(s): The primary efficacy variable will be an assessment of mesalazine (Asacol®) treatment compared with placebo on IBS symptoms. The main measurement parameters of symptom alleviation will be a global symptom score showing satisfactory symptom relief =50% of the time adequate symptoms relief >50% of the time, as as recorded on a weekly basis in a separate questionnaire for the duration of the treatment period.;Timepoint(s) of evaluation of this end point: The primary efficacy variable will be measured through weekly assessments of satisfactory symptom relief as evaluated by the patient from the start of treatment (week 0) up until the end of treatment (week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables will be assessments of mesalazine (Asacol®) treatment compared to placebo regarding: 1. IBS-symptom severity scale (IBS-SSS) 2. Inflammatory mediators measured by the Mucosal Patch Technology (MPT), e.g. neutrophil mediators, eosinophilic mediators, mast cell activity mediators and cytokines 3. Effect on immune cells and cytokines in mucosal biopsies 4. Levels of calprotectin in foeces 5. Individual symptom parameters in IBS-SSS and the IBS diary 6. Exploratory responder variables: a. satisfactory symptom relief =75% of the time b. reduction in IBS-SSS =50 at end of treatment compared to randomization;Timepoint(s) of evaluation of this end point: IBS-SSS will be evaluated on a biweekly basis for the entire duration of the treatment period (Week 0 to Week 8) with one final evaluation performed during the follow-up phase (Week 10). At each timepoint, the IBS-SSS as a whole and individual parametres will be compared against baseline. Inflammatory mediators, levels of calprotectin in foeces, effect on immune cells and cytokines in mucosal biopsies will be measured as change from baseline (Week 0) at the end of the treatment period (Week 8). | — |
Countries
Norway, Sweden
Contacts
Public ContactPrincipal Investigator
Sahlgrenska University Hospital
Outcome results
None listed