Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vanderbilt University Medical Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
