Original ResearchClinical-Alimentary TractRifaximin-Extended Intestinal Release Induces Remission in Patients With Moderately Active Crohn's Disease
Section snippets
Materials and Methods
This multicenter, randomized, double-blind, placebo-controlled trial was conducted at 55 centers across France, Germany, Hungary, Israel, Italy, Poland, and Russia, between September 2007 and September 2009.
The protocol was approved by the Institutional Review Boards/Ethics Committees at each center, and all patients gave written informed consent. The study was conducted according to the European Clinical Trials Directive (EudraCT number: 2007-001014-17) and registered with ClinicalTrials.gov
Characteristics and Disposition of Patients
A total of 402 patients received at least 1 dose of study drug: 101 patients in the placebo group, 104 patients in the rifaximin-EIR 400 mg twice daily group, 98 patients in the rifaximin-EIR 800 mg twice daily group, and 99 patients in the rifaximin-EIR 1200 mg twice daily group. Eight patients were excluded from the analysis because they did not take the study drug.
Thirty-six patients (9%) were not included in the per-protocol population due to at least one major protocol violation: 7 (7%)
Discussion
The results of this dose-range finding study suggest that rifaximin-EIR, at the dosage of 800 mg twice daily for 3 months, is safe and well tolerated, and effectively induces clinical remission of moderately active CD.
Abdominal pain was the CDAI parameter that was predominantly affected by the treatment, reaching a statistically significant difference from placebo in the rifaximin-EIR 800 mg twice daily (Supplementary Figure 1, Supplementary Figure 2, Supplementary Table 1, Supplementary Table 2
Acknowledgments
The authors would like to acknowledge Dr Maria Vittoria Fogli for her valuable contribution to the management of the study and dedicated assistance during the preparation of this article.
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European Clinical Trials Directive (EudraCT number: 2007-001014-17). ClinicalTrials.gov ID: NCT00528073.
Conflicts of interest The authors disclose the following: Dr Prantera has served as a consultant for and received research funding from Alfa Wassermann SpA and as advisory board member of Giuliani and Chiesi. Dr Lochs has served as a consultant and on Speakers Bureau for Alfa Wassermann SpA. Dr Gionchetti has served on the Advisory Board/Speakers Bureau for Alfa Wassermann SpA. Dr Danese has served as a speaker and an advisory board member for Ferring, Astra Zeneca, and Cosmo Pharmaceuticals. Dr Grimaldi is an employee of Alfa Wassermann SpA. The remaining author discloses no conflicts.
Funding This study was sponsored by Alfa Wassermann SpA, Bologna, Italy.