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Trial record 3 of 8 for:    rifaximin crohn

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

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ClinicalTrials.gov Identifier: NCT02240108
Recruitment Status : Recruiting
First Posted : September 15, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
The primary objective is to determine the efficacy of rifaximin DR tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in subjects 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Rifaximin DR Drug: Placebo Phase 3

Detailed Description:

RECD3126 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 subjects with active moderate Crohn's disease.

Subjects 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 subjects 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 in Subjects With Active Moderate Crohn's Disease
Actual Study Start Date : September 30, 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Rifaximin DR
Rifaximin delayed release (DR) oral tablets 800 mg BID administered continuously without dose adjustment for 52 weeks.
Drug: Rifaximin DR
Placebo Comparator: Placebo
Matching placebo BID administered continuously without dose adjustment for 52 weeks.
Drug: Placebo



Primary Outcome Measures :
  1. Clinical symptom remission [ Time Frame: Week 16 ]
    First of the co-primary efficacy measures: Change from baseline in (1) number of liquid/very soft stools AND (2) abdominal pain rating.

  2. Endoscopic response [ Time Frame: Week 16 to Week 17 ]
    Second of the co-primary efficacy measures: Change from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).


Secondary Outcome Measures :
  1. Clinical symptom remission [ Time Frame: Week 52 ]
    First of the key co-secondary efficacy measures: Change from baseline in (1) number of liquid/very soft stools AND (2) abdominal pain rating at Week 52.

  2. Endoscopic remission [ Time Frame: Week 52 ]
    Second of the key co-secondary efficacy measures: Change from baseline in SES-CD at Week 52.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Moderate, non-fistulizing Crohn's disease in the ileum and/or prior to randomization; and a SES-CD score of ≥7 (confirmed by centralized endoscopy reading).
  • During the Screening Period, the subject will need to have certain average daily scores for abdominal pain and average number of liquid/very soft stools.

Major Exclusion Criteria:

  • Pregnant or lactating females. Females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use a highly effective method(s) of contraception throughout their participation in the study.
  • Diagnosis of ulcerative or indeterminate colitis.
  • Diagnosis of Celiac Disease.
  • Bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed likely 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 bowel syndrome.
  • 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 subject is known by the Investigator to be steroid dependent.
  • Has used a biologic within 12 weeks of randomization.
  • Used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization.
  • Had rectal administration of 5-aminosalicylic acid (5-ASA) or corticosteroid enemas/foams/ suppositories within 2 weeks prior to screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240108


Contacts
Contact: Mary Jo Bullard 919 415 3390 maryjo.bullard@salix.com
Contact: Alyson Lineberry 919-415-3377 alyson.lineberry@salix.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Huntsville, Alabama, United States, 35802
United States, Arizona
Recruiting
Tucson, Arizona, United States, 85710
Recruiting
Tucson, Arizona, United States, 85712
Recruiting
Tucson, Arizona, United States, 85741
United States, Arkansas
Recruiting
Sherwood, Arkansas, United States, 72120
United States, California
Recruiting
Garden Grove, California, United States, 92845
Recruiting
La Jolla, California, United States, 92037
Recruiting
La Mirada, California, United States, 90638
Recruiting
Laguna Hills, California, United States, 92653
Recruiting
Los Angeles, California, United States, 90045
Recruiting
Northridge, California, United States, 91324
Recruiting
Oceanside, California, United States, 92056
Recruiting
San Diego, California, United States, 92103
United States, Colorado
Recruiting
Littleton, Colorado, United States, 80120
United States, Connecticut
Not yet recruiting
Waterbury, Connecticut, United States, 06708
United States, Florida
Recruiting
Boca Raton, Florida, United States, 33428
Recruiting
Clearwater, Florida, United States, 33756
Recruiting
Coral Gables, Florida, United States, 33173
Recruiting
Hollywood, Florida, United States, 33021
Recruiting
Inverness, Florida, United States, 34452
Recruiting
Lauderdale Lakes, Florida, United States, 33319
Recruiting
Maitland, Florida, United States, 32751
Recruiting
Miami Springs, Florida, United States, 33166
Recruiting
Miami, Florida, United States, 33136
Recruiting
Miami, Florida, United States, 33144
Not yet recruiting
Miami, Florida, United States, 33173
Recruiting
Orange Park, Florida, United States, 32073
Recruiting
Orlando, Florida, United States, 32803
Recruiting
Palm Harbor, Florida, United States, 33781
Recruiting
Port Orange, Florida, United States, 32127
Recruiting
Tampa, Florida, United States, 33603
United States, Georgia
Recruiting
Athens, Georgia, United States, 30606
Recruiting
Atlanta, Georgia, United States, 30322
Recruiting
Atlanta, Georgia, United States, 30338
Recruiting
Macon, Georgia, United States, 31201
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60624
Recruiting
Evanston, Illinois, United States, 60201
United States, Iowa
Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Recruiting
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Recruiting
Shreveport, Louisiana, United States, 71102
Withdrawn
West Monroe, Louisiana, United States, 71291
United States, Maryland
Recruiting
Hagerstown, Maryland, United States, 21742
Recruiting
Hollywood, Maryland, United States, 20636
United States, Massachusetts
Recruiting
Brockton, Massachusetts, United States, 02302
United States, Michigan
Recruiting
Caro, Michigan, United States, 48723
Not yet recruiting
Stevensville, Michigan, United States, 49127
Recruiting
Wyoming, Michigan, United States, 49519
United States, Minnesota
Recruiting
Plymouth, Minnesota, United States, 55446
United States, Mississippi
Recruiting
Ocean Springs, Mississippi, United States, 39564
Recruiting
Tupelo, Mississippi, United States, 60624
United States, Missouri
Recruiting
Bridgeton, Missouri, United States, 63044
Recruiting
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Recruiting
Vineland, New Jersey, United States, 08360
Withdrawn
Voorhees, New Jersey, United States, 08043
United States, New York
Recruiting
New York, New York, United States, 10016
Recruiting
New York, New York, United States, 10032
United States, North Carolina
Recruiting
Fayetteville, North Carolina, United States, 28304
Recruiting
Kinston, North Carolina, United States, 28501
United States, Ohio
Recruiting
Beavercreek, Ohio, United States, 45440
Recruiting
Cincinnati, Ohio, United States, 45219
Recruiting
Columbus, Ohio, United States, 43210
Recruiting
Kettering, Ohio, United States, 45429
Recruiting
Lima, Ohio, United States, 45806
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73102
United States, Oregon
Recruiting
Portland, Oregon, United States, 97210
United States, South Carolina
Recruiting
Columbia, South Carolina, United States, 29203
Recruiting
Fort Mill, South Carolina, United States, 29707
United States, Texas
Recruiting
Dallas, Texas, United States, 75231
Not yet recruiting
Houston, Texas, United States, 77036
Recruiting
Houston, Texas, United States, 77099
Recruiting
Humble, Texas, United States, 77338
Recruiting
San Antonio, Texas, United States, 78229
Recruiting
Tyler, Texas, United States, 75701
United States, Utah
Recruiting
Ogden, Utah, United States, 84405
Recruiting
West Jordan, Utah, United States, 84088
Recruiting
West Valley City, Utah, United States, 84120
United States, Virginia
Recruiting
Chesapeake, Virginia, United States, 23320
United States, Washington
Recruiting
Richland, Washington, United States, 99352
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT02240108     History of Changes
Other Study ID Numbers: RECD3126
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Crohn's Disease
Rifaximin
Clinical remission with endoscopic response
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Rifaximin
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents