One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
|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|
- 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).
- 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.
|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)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02240108
|Contact: Mary Jo Bullard||919 415 firstname.lastname@example.org|
|Contact: Alyson Lineberryemail@example.com|
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