Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy (REACT)
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|ClinicalTrials.gov Identifier: NCT04456517|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Inflammatory Bowel Disease||Drug: Ranolazine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||REACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated Diarrhea|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: Ranolazine, Then Placebo
- Participants first receive a Ranolazine 500 mg tablet twice daily for 12 weeks, they then receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms
500 mg tablet
Ranolazine-matched placebo tablet
Experimental: Placebo, Then Ranolazine
- Participants first receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks, they then receive a Ranolazine 500mg tablet twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms
500 mg tablet
Ranolazine-matched placebo tablet
- Mean change in daily number of loose stools from baseline [ Time Frame: Baseline to Week 36 ]Daily number of loose stools and antidiarrheal use will be collected directly from all subjects using MyCap or, if installation and use of an app is not possible, through email with a survey link. MyCap is a secure mobile application developed by the REDCap team at Vanderbilt and integrated into the REDCap database system.
- Mean change in Crohn's Disease Activity Index (CDAI) score [ Time Frame: Baseline to Week 36 ]The Crohn's Disease Activity Index (CDAI) combines weighted scores of clinical and laboratory variables to estimate disease severity. The CDAI consists of eight variables, two of which are subjective, related to the disease, each weighted according to its ability to be predictive of disease activity. The absolute score ranges from 0 to 600. CDAI scores of less than 150 indicate a clinical remission and scores over 450 indicate severely active disease. Since blood draws will not be performed as part of this study, the hematocrit component of the CDAI will not be assessed.
- Mean change in Harvey Bradshaw Index (HBI) score [ Time Frame: Baseline to Week 36 ]The Harvey-Bradshaw index (Harvey-Bradshaw Index - HBI) assesses the degree of illness (activity) in patients with Crohn's disease. The HBI consists of 5 items with a minimum score of 0 and a maximum attainable score depending on the number of stools the patient identifies per day. HBI scores < 5 are defined as clinical remission, HBI between 5 and 7 as mild disease, HBI between 8 and 16 as moderate disease, and HBI > 16 as severe disease.
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score [ Time Frame: Baseline, Day 84, and Day 168 ]The SIBDQ is a 10-item questionnaire measuring quality of life in four domains: bowel symptoms, emotional health, systemic symptoms, and social function and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). The absolute score ranges are from 10 (poor Health-related quality of life) to 70 (optimum Health-related quality of life).
- Patient Health Questionnaire (PHQ-9) score [ Time Frame: Baseline, Day 84, Day 168 ]
The PHQ-9 is a 9-item questionnaire that screens for the presence and severity of depression and can be used to make a depression diagnosis using DSM-IV criteria.
The PHQ-9 is scored on a 3-point Likert scale from 0 (not at all) to 3 (nearly every day). The absolute score ranges are from 0 (none or minimal depression) to 27 (severe depression).
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): NCT04456517
|Contact: Sarah L Fergusonemail@example.com|
|Contact: Tina Higginbothamfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212|
|Contact: Sarah Ferguson 615-875-3196 email@example.com|
|Contact: Tina Higginbotham 615-322-4643 firstname.lastname@example.org|
|Principal Investigator: Dawn B. Beaulieu, MD|
|Principal Investigator:||Dawn B. Beaulieu, MD||Vanderbilt University Medical Center|