Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Treatments: Proglumide

Criteria

Subjects are eligible with a history of chronic pancreatitis as defined by the Cambridge radiographic classification with abnormal pancreatic side branches but without main pancreatic duct obstructing calcifications.

Inclusion Criteria:

• Males or females age 18 to 75 years of age

• Clinical symptoms of chronic pancreatitis

• Plus confirmation of chronic pancreatitis with imaging (Cambridge classification), EUS, biopsy, or fecal elastase <200µg/g, or abnormal 72 hr fecal fat and radiographic evidence of CP.

• Pain not adequately controlled with medications

• Pain of at least 5 on a numeric pain scale of 0-10

• Stable doses of anti-diabetic medication for at least 90 days prior to screening.

• Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide).

• Both males and females must be willing and able to continue contraception to prevent pregnancy for 3 months after the completion of the study.

Exclusion Criteria:

• Currently abusing alcohol (more than three drinks in a day or more than seven drinks per week) or nonprescription drugs

• Pregnant or lactating, or unwilling to prevent pregnancy

• Renal insufficiency; CKD; GFR<60

• Unable to sign consent or maintain a diary

• Liver enzymes > 2x ULN, Hgb <8.5, Creat>2; HgbA1c>8

• Type 1 Diabetes

• Subjects with confirmed cirrhosis

• Evidence of active gallbladder disease or gallbladder dyskinesia