Overview

Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.
Phase:
Phase 2
Details
Lead Sponsor:
Alfa Wassermann S.p.A.
Alfasigma S.p.A.
Treatments:
Rifamycins
Rifaximin