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)
Completed
Forest Laboratories
Phase 3
2008-01-01
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 (formerly
Eurand).
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
Completed
Forest Laboratories
Phase 4
2010-06-01
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
(formerly Eurand).
PR-018: An Open-Label, Safety Extension of Study PR-011
Completed
Forest Laboratories
Phase 4
2010-07-01
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).
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
Terminated
University of Florida
Phase 1
2010-08-02
The purpose of this study is to evaluate two different treatments in subjects with chronic
pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
Terminated
Eurand Pharmaceuticals
Phase 1
2010-08-02
The purpose of this study is to evaluate two different treatments in subjects with chronic
pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
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