Irritable Bowel Syndrome
Conditions
Keywords
Mesalazine in Irritable Bowel Syndrome
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.
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.
Interventions
DRUGMesalazine
Mesalazine 800mg t.i.d. 12 weeks
DRUGPlacebo
Placebo cpr, t.i.d. 12 weeks
Sponsors
SOFAR S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* IBS patients with positive diagnosis inclosing Rome III criteria
Exclusion criteria
* Any organic or metabolic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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?. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 3 months |
Countries
Italy
Outcome results
None listed