Mesalazine Therapy in Patients With Irritable Bowel Syndrome (IBS-02/07)

SOFAR

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: Mesalazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626288

IBS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion criteria

• Any organic or metabolic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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187 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Mesalazine cpr 800 mg t.i.d. for 12 weeks

Treatment:

Drug: Mesalazine

B

Placebo Comparator group

Description:

Placebo cpr t.i.d. for 12 weeks

Treatment:

Drug: Placebo