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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02240121

Run by

Bausch Health Americas, Inc.

People needed

80

Starts

2014-08-21

Expected to finish

2017-08-16

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Hills, California, United States
• Study site — Orange, California, United States
• Study site — San Carlos, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Bristol, Connecticut, United States
• Study site — Danbury, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Coral Springs, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Homestead, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Plant City, Florida, United States
• Study site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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