MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE III FOR VIOKASE 16 FOR STEATORRHEA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In order to answer the primary question does Viokase 16 decrease steatorrhea in subjects with chronic pancreatitis and steatorrhea exocrine pancreatic insufficiency EPI; a study has been designed that proposes to evaluate the efficacy of Viokase 16 against a placebo. The efficacy will be based on a comparison of the coefficient of fecal fat absorption CFA between Viokase 16 and placebo. The subjects will have baseline studies done off any pancreatic enzyme therapy. These studies will include laboratory blood work, urinalysis, fecal elastase and 100g fat diet studies with 72 hour stool collections for quantitative fecal fats and monitoring of concomitant medications will be done during the study period. To answer the secondary question; subjects will be given a diary at the beginning of the study to record necessary information about food, drug intake, stool frequency and characteristics of stools. Subjects will be on a proton pump inhibitor for the entire study.