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

NCT02240121 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-09-10

Study results available
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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.

Conditions

Interventions

DRUG

Rifaximin EIR

Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.

DRUG

Placebo

Placebo matching to rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.

Sponsors & Collaborators

  • Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC

    collaborator UNKNOWN

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsey Mathew · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-21
Primary Completion
2017-08-16
Completion
2017-08-16

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02240121 on ClinicalTrials.gov