Viokase 16, Viokase16 Plus Nexium and Nexium Alone (AZ)
Chronic Pancreatitis
About this trial
This is an interventional treatment trial for Chronic Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Males and females age 18 to 75 years inclusive. Female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study.
- History of abdominal pain associated with chronic pancreatitis
Evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal CT showing a dilated pancreatic duct and/or atrophy, an abnormal Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (EUS), fecal elastase > 100ug/g stool, or serum trypsinogen > 20ng/ml
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Exclusion Criteria:
- Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.
- Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.
- Female subjects who are pregnant or lactating
- Subject use of enzyme therapy other than that called for in this study
- Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.
- Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Nexium alone
Placebo to Nexium, alone
Viokase 16 (pancrelipase) + Nexium
Viokase 16 + placebo to Nexium
Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month.
Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone