Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
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 even when their Crohn's disease is in remission. Diarrhea and/or abdominal
 pain that is not responsive to standard therapies can significantly affect a patient's
 quality of life and ability to work. The purpose of this study is to test the safety and
 effectiveness of the drug ranolazine in reducing Crohn's disease-associated diarrhea and
 other symptoms. Ranolazine is approved by the US Food & Drug Administration (FDA) for chronic
 angina (a heart condition). This study is investigating if ranolazine could be used in the
 setting of Crohn's disease.
Inclusion Criteria:

 -  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 Criteria:

 -  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, clarithromycin, nefazodone,
 nelfinavir, ritonavir, indinavir, and saquinavir, diltiazem, verapamil, erythromycin,
 fluconazole, grapefruit juice or grapefruit-containing products, rifampin, rifabutin,
 rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's Wort.

 -  Concurrent use of statin medications, Digoxine, TCA antidepressants or
 anti-psychotics, or metformin

 -  Concurrent use of OCT2 substrates

 -  Concurrent use of drugs transported by P-gp or drugs metabolized by CYP2D6

 -  Concurrent use of drugs known to prolong the QT interval

 -  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)