Safety and Efficacy of Eurand PEP Microtabs in Pediatric Patients with CF Pancreatic Insufficiency
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
This open-label study evaluated the safety and efficacy of Eurand pancreatic enzyme product (PEP) microtabs in pediatric patients under age 7 with Cystic Fibrosis and Exocrine Pancreatic Insufficiency.
1 Days - 6 Years
P. aeruginosa status:
B. cepacia status:
Other Primary Eligibility Requirements:
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trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
Two multicenter studies were conducted: a randomized, double-blind, placebo-controlled, crossover trial in patients > or =7 years of age (34 subjects were enrolled) and a supplemental, open-label study in children <7 years of age (19 subjects were enrolled). In the randomized trial, EUR-1008 treatment compared to placebo resulted in a significantly higher mean Coefficient of Fat Absorption (88.3% vs. 62.8%, respectively) and Coefficient of Nitrogen Absorption (87.2% vs. 65.7%, respectively) (both p<0.001) and reduced the incidence of malabsorption signs and symptoms in 32 evaluable patients.
In the supplemental study, 11 of 19 patients met the criteria for responder with EUR-1008 at the end of the study vs. 10 of 19 patients at screening (previous PEP), and improvements in clinical symptoms were reported with EUR-1008 treatment.
EUR-1008 was safe and well tolerated, and no serious drug-related AEs were reported in either study.