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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
410
Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease
CHU Amiens, Hôpital Nord
Amiens, France
Hôpital Saint André
Bordeaux, France
CHU Grenoble, Hôpital Michallon
Grenoble, France
CHU de Nice, Hôpital de l'Archet II
Nice, France
CHU de Rouen, Hôpital Charles Nicolle
Rouen, France
Charité Campus Mitte
Clinical remission (Crohn's Disease Activity Index < 150 points)
Time frame: After 12 weeks of treatment
Clinical response (reduction of baseline CDAI score by 100 points or more)
Time frame: Any time during the 12 weeks of treament
Clinical response (reduction of baseline CDAI by 70 points or more)
Time frame: At any time during the 12 weeks of treatment
Time to obtain clinical response and remission
Time frame: During the 12 weeks of treatment
Maintenance of clinical remission
Time frame: 2 weeks after the end of the 12 weeks of treatment
Maintenance of clinical remission
Time frame: 12 weeks after the end of the 12 weeks of treatment
Number of treatment failures
Time frame: During the 12 weeks of treatment
Definition of therapeutic dose to be used in subsequent phase III trials.
Time frame: After statistical analysis of the results
Adverse events
Time frame: Throughout the study
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Berlin, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin
Frankfurt am Main, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Abteilung Gastroenterologie, Charité Campus Benjamin Franklin
Hindenburgdamm 30, Berlin, Germany
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