One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
Status:
Terminated
Trial end date:
2017-10-06
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.
Collaborator:
Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC