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Study Name: 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.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00981214?term=eurand+and+cystic+fibrosis&rank=2
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

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.

Citation:

J Cyst Fibros 2009;8(6):405-17

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