Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
Chronic pancreatitis is a rare but debilitating condition associated with chronic abdominal
pain, diarrhea, diabetes, and an 8-fold increased risk for the development of pancreatic
cancer. Unfortunately, there is no available treatment to prevent the progression of chronic
pancreatitis, and most subjects require narcotic medications to control the pain. A receptor
protein call the CCK-B receptor becomes activated in chronic pancreatitis and is in part
responsible for the scar tissue or fibrosis that occurs and responsible for the cancer risk.
In mice with chronic pancreatitis, the inflammation and damage was reversed with an old drug
called proglumide that blocks the activation of the CCK-B receptor. Proglumide has also been
shown to possibly reduce pain.
This protocol involved a 2-Part study to test the safety of oral proglumide in those with
confirmed chronic pancreatitis and the second goal is to determine if proglumide improves
pain and function of the pancreas. Part-1 is an open-labelled Lead-in Study of N=8 subjects
over a 12-week treatment period. Part-2 is a randomized double blind pseudo cross over study
where subjects will be treated in Arm A (placebo for 12 weeks followed by 12 weeks of
proglumide) and Arm B ( proglumide for 24 weeks).