drugset / Trial / NCT02240108

One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease

NCT02240108

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease. A key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.

Timeline

Start
2014-10-28
Primary completion
2017-10-06
Completion
2017-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifaximin Other / unclassified 400 mg Oral

Indications