NCT02240108.

Trial name or title	A Double‐Blind, Placebo‐Controlled, Parallel‐Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks
Methods	A double‐blind, placebo‐controlled, parallel‐group, multicenter, multi‐regional, 52‐week study to assess the efficacy and safety of rifaximin DR tablets for the induction of clinical remission and endoscopic response at 16 weeks followed by clinical and endoscopic remission after 52 weeks of continuous therapy in subjects with active moderate Crohn's disease
Participants	Participants are 18 years and older with Crohn's disease
Interventions	Rifaximin delayed release (DR) oral tablets 800 mg BID administered continuously without dose adjustment for 52 weeks compared to a matching placebo
Outcomes	Primary outcomes: 1) Clinical symptom remission at 16 weeks‐ Change from baseline in number of liquid/very soft stools and abdominal pain rating 2) Endoscopic response at 16 to 17 weeks‐ Change from baseline in simple endoscopic score for Crohn's Disease (SES‐CD) Secondary outcomes: 1) Clinical symptom remission at 52 weeks‐ Chnge from baseline in number of liquid/very soft stools and abdominal pain rating at 52 weeks 2) Endoscopic remission at 52 weeks‐ Second of the key co‐secondary efficacy measures: Chnage from baseline in SES‐CD at week 52
Starting date	September 30, 2014
Contact information	No contact information stated
Notes