ULTRASE MT20 FOR CORRECTION OF STEATORRHEA IN PATIENTS WITH CYSTIC FIBROSIS

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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. This is a multicenter phase III, randomized, double-blind, placebo-controlled crossover study evaluating the safety and efficacy of Ultrase MT20 (pancreatic enzyme product). The study consists of an outpatient screening phase of up to 11 days, 2 study enzyme stabilization periods and 2 inpatient stays lasting 6-7 days each for comparing active study enzymes to placebo in amount of fecal fat measured during a 72-hour stool collection. A sufficient numer of CF subjects will be randomized in order to get a total of 24 evaluable subjects from approximately 8 sites. This is to meet the FDA mandate that after 2008, all enzyme products must submit efficacy/safety data or be pulled from the market.