Safety and Efficacy of Eurand PEP Microtabs in Pediatric Patients with CF Pancreatic Insufficiency
Study Type:
Interventional
Intervention Category:
Nutritional-GI Therapies
Study Sponsor:
Aptalis
Study Phase:
3
Recruitment Status:
Trial Completed
Study Drug(s):
PEP Microtabs
Number of Participants Being Recruited:
15
Single / Multi-Center:
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.
ELIGIBILITY
Age:
1 Days - 6 Years
FEV1:
Not Applicable
P. aeruginosa status:
Not applicable
B. cepacia status:
Not applicable
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
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.
Secondary Efficacy:
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.
Safety:
EUR-1008 was safe and well tolerated, and no serious drug-related AEs were reported in either study.
