A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn?s disease - RETIC/03/06

• Conditions: moderate active Crohn disease; MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2007-001014-17-IT
• Lead Sponsor: ALFA WASSERMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

Male or female, 18 to 75 years old, Crohn disease diagnosis localised at ileum or colon and radiologically or spectroscopically documented for at least 3 months, patients with CDAI between 220 and 400, patients capable of and willing to conform to the study protocol, ICF signed
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients potentially needing immediate surgery for Crohn disease, including patients with occlusive symptoms, patients with other infectious, ischemic, or immunological diseases with gastrointestinal involvement

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy (remission induction) and safety of 3 doses of RIfaximin-EIR vs placebo in the treatment of moderate active Crohn's disease;Secondary Objective: not applicable;Primary end point(s): clinical remission afetr 12 weeks of treatment