Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis (ProCP)
Safety Issues, Pain, Pancreas Fibrosis
About this trial
This is an interventional treatment trial for Safety Issues focused on measuring Cholecystokinin, Pain, Proglumide, Diabetes, Pancreatitis
Eligibility 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
Sites / Locations
- Georgetown UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Proglumide
Arm 1. Placebo for first 12 weeks. Placebo is a fiber filler called Avicel and is given by mouth three times daily. Note: After 12 weeks on placebo, these subjects will receive proglumide 400 mg orally three times daily open labeled for 12 additional weeks.
Proglumide therapy 400 mg by mouth three times daily for 12 weeks in a blinded fashion followed by continued proglumide 400 mg by mouth three times daily for 12 additional weeks in an open labeled fashion. Hence this arm receives proglumide for a total of 24 weeks.