Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

Summary

The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

Timeline

Start

2006-05

Primary completion

2006-11

Completion

2006-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); EUR-1008 (APT-1008) vs Placebo; p <0.001; Least Square (LS) Mean Difference -25.52 (95% CI -31.73 to -19.32); ANOVA NCT00297167 ↗

paper In the randomized trial, EUR-1008 treatment compared to placebo resulted in a significantly higher mean CFA (88.3% vs. 62.8%, respectively) PMID 19683970 ↗

Publications

• Wooldridge JL, Heubi JE, Amaro-Galvez R, Boas SR, Blake KV, Nasr SZ, Chatfield B, McColley SA, Woo MS, Hardy KA, Kravitz RM, Straforini C, Anelli M, Lee C. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009 Dec;8(6):405-17. doi: 10.1016/j.jcf.2009.07.006. Epub 2009 Aug 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pancrelipase	Protein / enzyme biologic	5000 iu	Oral
Subject	Pancrelipase	Protein / enzyme biologic	10000 iu	Oral
Subject	Pancrelipase	Protein / enzyme biologic	15000 iu	Oral
Subject	Pancrelipase	Protein / enzyme biologic	20000 iu	Oral

Indications