SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and
amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be
formulated without enteric coating for administration either as a capsule or as a dosing
solution dissolved in water or juice. The purpose of the present study is to provide efficacy
and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral
Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).