One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT02240121|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2014
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Rifaximin DR Drug: Placebo||Phase 3|
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 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|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||July 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 1, 2020|
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.
- 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.
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): NCT02240121
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