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

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

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated early due to difficulty in enrollment and lack of clinical study drug access.”

Drugs

Indications