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

This study is currently recruiting participants.
Verified April 2017 by Valeant Pharmaceuticals International, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02240108
First Posted: September 15, 2014
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
  Purpose
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 Intervention Phase
Crohn's Disease Drug: Rifaximin DR Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

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


Estimated Enrollment: 660
Actual Study Start Date: September 30, 2014
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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

  Show 78 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
  More Information

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT02240108     History of Changes
Other Study ID Numbers: RECD3126
First Submitted: September 11, 2014
First Posted: September 15, 2014
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
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents