Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT03859869
Eligibility Criteria:
Inclusion Criteria:
* Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a life expectancy of at least 5 months at screening
* Participant's pancreatic cancer must involve the head and/or neck of the pancreas
* Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g stool at screening
* A positive Sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat \> 7 g/day, or positive stool results by Sudan stain) within 1 week of screening -- Positive stool results are defined as increased level of neutral OR total fats
Exclusion Criteria:
* Participant has neuroendocrine pancreatic cancer
* Participant has fibrosing colonopathy
* Participant has any other malignancy within 1 year of screening
* Participant has uncontrolled gout, including those with a recent flare within 60 days of screening
* Participant has other significant organ or bone marrow abnormality within 60 days of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03859869
Study Brief:
Protocol Section:
NCT03859869