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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02240108 |
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Date of registration:
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11/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
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Scientific title:
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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 |
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Date of first enrolment:
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October 28, 2014 |
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Target sample size:
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81 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02240108 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Lindsey Mathew |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bausch Health Americas, Inc. |
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Key inclusion & exclusion criteria
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Major Inclusion Criteria:
- Moderate, non-fistulizing Crohn's disease in the ileum and/or colon prior to
randomization; and a SES-CD score of =7 (confirmed by centralized endoscopy reading).
- During the screening period, the participant 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 participant 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Placebo
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Drug: Rifaximin EIR
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Primary Outcome(s)
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Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16
[Time Frame: Week 16]
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Number of Participants With Endoscopic Response Between Week 16 and 17
[Time Frame: Baseline, Week 16 to 17]
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Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52
[Time Frame: Week 52]
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Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16
[Time Frame: Week 16]
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Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52
[Time Frame: Week 52]
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Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52
[Time Frame: Week 52]
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Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16
[Time Frame: Week 16]
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Number of Participants With Endoscopic Response at Week 52
[Time Frame: Baseline, Week 52]
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Secondary Outcome(s)
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Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time
[Time Frame: From Baseline to Week 52]
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Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16
[Time Frame: Week 16]
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Number of Participants With SES-CD Score of 0 at Week 52
[Time Frame: Week 52]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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