drugset / Trial / NCT02240108
One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
Phase 3
Terminated
81 enrolled
Bausch Health Americas, Inc.
Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rifaximin | Other / unclassified | 400 mg | Oral |