Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.

• Conditions: Treatment of active, moderate Crohn’s disease; MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-002821-24-IT
• Lead Sponsor: ALFA WASSERMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-27
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The study will include patients with active, moderate Crohn’s disease defined by a CDAI score of = 220 and = 400, localised in the ileocolon or colon (documented either radiologically or endoscopically at least 3 months before inclusion in the study).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Patients with symptoms attributed to Short Bowel Syndrome, patients potentially requiring immediate surgery for CD will be not included into the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified