Table 2.
Study calendar.
| Screening visit, from 7 to 30 days | Enrollment visit, day 0 | Treatment days 1-7 | Follow-up visit, day 8 (+3-day window) | ||
| Required assessments | |||||
| Informed consent | ✓ | ||||
| Medical historya | ✓ | ||||
| Height and weight | ✓ | ||||
| Physical examination | ✓ | ✓ | |||
| Vital signs | ✓ | ✓ | |||
| ECOGb performance status | ✓ | ✓ | ✓ | ||
| EKGc | ✓ | ✓ | |||
| Blood chemistriesd | ✓ | ✓ | |||
| Hemoglobin, absolute neutrophil count, and platelets | ✓ | ✓ | |||
| Urine pregnancy | ✓ | ✓ | |||
| Medication assessmente | ✓ | ✓ | ✓ | ||
| Adverse event assessment | ✓ | ✓ | |||
| Questionnaires | |||||
| Physician questionnaire | ✓ | ||||
| Study coordinator questionnaire | ✓ | ✓ | |||
| Patient questionnaire (VASf, BPIg, PROMISh, and COMPATi) | ✓ | ✓ | ✓ | ||
| Medication diary | ✓ | ✓ | ✓ | ||
aMedical history and establishment of suspected or definite chronic pancreatitis diagnosis may occur at any time before trial entry.
bECOG: Eastern Cooperative Oncology Group.
cEKG: electrocardiogram.
dWill include at a minimum: electrolytes, glucose, blood urea nitrogen, creatinine and creatinine clearance, calcium, and hepatic function panel.
eWill include detailed use of rescue pain medications and opioids use.
fVAS: Visual Analog Score.
gBPI: Brief Pain Inventory.
hPROMIS: Patient-Reported Outcomes Measurement Information System.
iCOMPAT: Comprehensive Pain Assessment Tool for Chronic Pancreatitis.