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Study Name: Safety and Effectiveness of the Eurand Pancreatic Enzyme Supplement in People with CF
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: 30
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
In this study, researchers examined the effect of a pancreatic enzyme drug on fat absorption. The drug contains approximately 14 pancreatic enzymes, coenzymes and cofactors in a delayed-release capsule. The drug is intended to provide a consistent dose of enzymes over time and improve overall nutritional health. Approximately 90 percent of people with CF need to take pancreatic enzymes to help them absorb fat and protein properly. Pancreatic enzyme supplements help CF patients to enhance digestion, improve growth, reduce gastrointestinal problems, and contribute to general nutritional health. In addition, use of pancreatic enzymes also has contributed to a significant increase in the lifespan of CF patients. Subjects in the study took either a placebo or the drug (EUR-1008M) and were at least 7 years of age and weighed less than 155 lbs.
ELIGIBILITY
Age: >= 7 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/NCT00297167?term=eurand+cystic+fibrosis&rank=1
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):405-417

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