Cystic Fibrosis Clinical Trial
Official title:
A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)
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).
This is a multicenter, randomized, open-label, crossover study in pediatric participants
with EPI due to CF. The study will be carried out in infants between 1 and 12 months of age.
The study comprises of a screening period (up to 10 days) followed by 2 treatment periods
(10 days each). During the screening period, all participants will be administered Zenpep®
5,000 (pancrelipase) mixed with a small amount of apple sauce. Once determined eligible for
participation, participants will be randomized into 1 of 2 treatment sequences. Each
sequence corresponds to taking one treatment in the first period and the other treatment in
the second period, and were administered EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed
release capsule) 3,000 lipase units capsule either mixed with apple juice using a syringe
nurser or apple sauce using a spoon.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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