Status:
TERMINATED
Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Crohn's Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Crohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (GI) tract. Some patients still experience persistent diarrhea or other symptoms such as abdominal pain eve...
Eligibility Criteria
Inclusion
- Meet diagnostic criteria for Crohn's Disease with active diarrhea Either with active disease or in remission (as defined by endoscopic or radiographic findings) but experiencing symptoms (e.g., diarrhea, abdominal pain)
- Have greater than three loose stools per day
Exclusion
- Male and female subjects \<18 years of age
- Significant change in medication including prednisone, antidepressant medications, or stimulants within the last 4 weeks
- a. Allowances include: Rectal hydrocortisone, rectal mesalamine, addition of prednisone (up to 20mg) for flares, etc.
- Regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use
- Severe psychiatric disease including schizophrenia, psychosis, suicidal depression
- Previous use of ranolazine within 2 months prior to enrollment
- Prior use of ranolazine which was discontinued for safety or tolerability
- Metabolic derangement defined as liver function tests \>3x upper limit of normal or severe renal disease defined as calculated creatinine clearance \<30 mL/min
- Have liver cirrhosis
- Concurrent use of CYP3A inhibitors, inducers, or substrates
- a. These may include: ketoconazole, itraconazole, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, clarithromycin, or rifampin, rifapentine, phenobarbital, phenytoin, and St. John's Wort, digoxin.
- A family history of (or congenital) long QT syndrome or known acquired QT interval prolongation
- Inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment
- Patients who are pregnant or breastfeeding
- Patients who are enrolled in other investigational drug studies or who have taken investigational drugs within 30 days before enrollment
- Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history) or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)
Key Trial Info
Start Date :
October 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04456517
Start Date
October 18 2022
End Date
April 11 2024
Last Update
February 6 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212