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

Last updated: September 6, 2019
Sponsor: Bausch Health Americas, Inc.
Overall Status: Terminated

Phase

3

Condition

Crohn's Disease

Colic

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT02240121
RECD3125
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Major Inclusion Criteria:

  • Moderate, non-fistulizing Crohn's disease in the ileum and/or colon prior torandomization; and a SES-CD score of ≥7 (confirmed by centralized endoscopy reading).

  • During the screening period, the participant will need to have certain average dailyscores for abdominal pain and average number of liquid/very soft stools.

Exclusion

Major Exclusion Criteria:

  • Pregnant or lactating females. Females of childbearing (reproductive) potential musthave a negative serum pregnancy test at screening and agree to use a highly effectivemethod(s) of contraception throughout their participation in the study. Diagnosis ofulcerative or indeterminate colitis.

  • Diagnosis of Celiac Disease.

  • Bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemedlikely for Crohn's disease during the study period.

  • Presence of an ileostomy or colostomy.

  • Known fixed symptomatic stenosis/stricture of the small or large bowel.

  • Had more than one segmental colonic resection.

  • Had more than 3 small bowel resections or symptoms associated with short bowelsyndrome.

  • Current evidence of peritonitis.

  • History or evidence of colonic mucosal dysplasia.

  • History or evidence of adenomatous colonic polyps that have not been removed.

  • Unwilling to be tapered off corticosteroids by Week 8 or the participant is known bythe Investigator to be steroid-dependent.

  • Has used a biologic within 12 weeks of randomization.

  • Used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugswithin 8 weeks prior to randomization.

  • Had rectal administration of 5-aminosalicylic acid (5-ASA) or corticosteroidenemas/foams/ suppositories within 2 weeks prior to screening visit.

Study Design

Total Participants: 80
Study Start date:
August 21, 2014
Estimated Completion Date:
August 16, 2017

Study Description

RECD3125 is a double-blind, placebo-controlled, parallel-group, multicenter, multiregional, 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 participants with active moderate Crohn's disease.

Participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. Ileocolonoscopy will be performed on all participants at baseline, between Weeks 16 and 17 (end of the Induction Phase), and following completion of the 36-week Long Term Treatment Phase (Week 52).

Connect with a study center

  • Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Tucson, Arizona 85724
    United States

    Site Not Available

  • Little Rock, Arkansas 72211
    United States

    Site Not Available

  • North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Bakersfield, California 93301
    United States

    Site Not Available

  • Los Angeles, California 90067
    United States

    Site Not Available

  • Mission Hills, California 91345
    United States

    Site Not Available

  • Orange, California 92868
    United States

    Site Not Available

  • San Carlos, California 94070
    United States

    Site Not Available

  • Torrance, California 90503
    United States

    Site Not Available

  • Denver, Colorado 80045
    United States

    Site Not Available

  • Bristol, Connecticut 06010
    United States

    Site Not Available

  • Danbury, Connecticut 06810
    United States

    Site Not Available

  • Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Coral Springs, Florida 33071
    United States

    Site Not Available

  • Hialeah, Florida 33012
    United States

    Site Not Available

  • Homestead, Florida 33030
    United States

    Site Not Available

  • Largo, Florida 33777
    United States

    Site Not Available

  • Miami, Florida 33165
    United States

    Site Not Available

  • Orlando, Florida 32803
    United States

    Site Not Available

  • Plant City, Florida 33563
    United States

    Site Not Available

  • Winter Haven, Florida 33880
    United States

    Site Not Available

  • Winter Park, Florida 32789
    United States

    Site Not Available

  • empty

    Atlanda, Georgia 30342
    United States

    Site Not Available

  • Atlanta, Georgia 30342
    United States

    Site Not Available

  • Columbus, Georgia 31909
    United States

    Site Not Available

  • Urbana, Illinois 61801
    United States

    Site Not Available

  • Evansville, Indiana 47714
    United States

    Site Not Available

  • Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Pratt, Kansas 67124
    United States

    Site Not Available

  • Madisonville, Kentucky 42431
    United States

    Site Not Available

  • Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Towson, Maryland 21204
    United States

    Site Not Available

  • Marlborough, Massachusetts 01752
    United States

    Site Not Available

  • Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Troy, Michigan 48098
    United States

    Site Not Available

  • Jackson, Mississippi 39202
    United States

    Site Not Available

  • Mexico, Missouri 65265
    United States

    Site Not Available

  • Reno, Nevada 89511
    United States

    Site Not Available

  • Marlton, New Jersey 08053
    United States

    Site Not Available

  • Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Brooklyn, New York 11235
    United States

    Site Not Available

  • Flushing, New York 11355
    United States

    Site Not Available

  • Great Neck, New York 11021
    United States

    Site Not Available

  • New York, New York 10016
    United States

    Site Not Available

  • Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Jacksonville, North Carolina 28546
    United States

    Site Not Available

  • Kinston, North Carolina 28501
    United States

    Site Not Available

  • Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Mentor, Ohio 44060
    United States

    Site Not Available

  • Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Charleston, South Carolina 29406
    United States

    Site Not Available

  • empty

    Gaffney, South Carolina 29341
    United States

    Site Not Available

  • Greenville, South Carolina 29615
    United States

    Site Not Available

  • Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Nashville, Tennessee 37211
    United States

    Site Not Available

  • Arlington, Texas 76012
    United States

    Site Not Available

  • Fort Worth, Texas 76104
    United States

    Site Not Available

  • Pasadena, Texas 77505
    United States

    Site Not Available

  • Southlake, Texas 76092
    United States

    Site Not Available

  • Clinton, Utah 84015
    United States

    Site Not Available

  • Leesburg, Virginia 20176
    United States

    Site Not Available

  • Bellevue, Washington 98004
    United States

    Site Not Available

  • Madison, Wisconsin 53705-2281
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.