Phase 4 Pancreatitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who are able to give consent and follow study procedures
• People who are stable outpatients within 12 months after an acute pancreatitis episode and have been diagnosed with a condition called exocrine pancreatic insufficiency (EPI), confirmed by a specific stool test result within the past 3 months
• People whose EPI-related symptoms score at or above a certain threshold on a symptom tracking tool at the start of the study (confirm with trial site)
• People who have stopped taking pancreatic enzyme replacement therapy (prescription or over-the-counter) for at least 7 days before the study begins
• People who have fully completed all required treatment (surgical, endoscopic, or drainage procedures) for a severe form of pancreatitis involving tissue death
• People whose body weight is between 40 and 120 kg
• Women who could become pregnant must have a negative pregnancy test at the start of the study and must use at least one approved form of birth control from the start of the study until 30 days after the last dose of study medication
• Women who cannot become pregnant — either due to being postmenopausal (with specific age and hormone level criteria) or having had a surgical procedure such as removal of both ovaries, both fallopian tubes, or the uterus — do not need a pregnancy test

Who may not be able to join:

• People whose acute pancreatitis was caused by a cystic growth on the pancreas, a physical injury, or surgery (though people whose pancreatitis followed a specific gut procedure called ERCP may still be considered)
• People with a confirmed diagnosis of chronic pancreatitis as defined by established medical guidelines
• People with pancreatic cancer or other active cancers requiring ongoing systemic treatment (though people with certain treated, non-spreading skin or cervical cancers may still be considered)
• People with conditions affecting the gut lining or bowel that could interfere with test results, such as inflammatory bowel disease, coeliac disease, or active gut infections
• People with a condition called gastroparesis, where the stomach empties too slowly
• People with a confirmed or suspected cystic tumour associated with a specific type of pancreatic duct enlargement, or where such a tumour is believed to have caused the pancreatitis
• People who have previously had pancreatic surgery or certain upper digestive tract surgeries, including gastric bypass or full removal of the pancreas
• People who are pregnant or breastfeeding
• People with a life expectancy of less than 6 months due to serious ongoing conditions such as severe heart failure or advanced lung disease, or other conditions the study doctor determines would prevent safe participation
• People who are currently incarcerated

Important: Always verify eligibility with the trial site directly before applying.