A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)
The primary efficacy objective of this study is to evaluate the difference in coefficient of
fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low
dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in
participants with EPI associated with CP. This study is sponsored by Aptalis Pharma
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
A study to determine the safety, effectiveness, and acceptability of 2 methods of
administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000
lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic
insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma
PR-018: An Open-Label, Safety Extension of Study PR-011
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008)
3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with
exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.
The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as
compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with
Cystic Fibrosis in subjects 12 years of age and older.
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