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This is an open-label study to evaluate the safety and efficacy of Eurand pancreatic enzyme product (PEP) microtabs in pediatric patients under age 7 with Cystic Fibrosis and Exocrine Pancreatic Insufficiency.
This study is an open-label, multiple-dose, single-treatment, multicenter trial in pediatric patients with CF and exocrine pancreatic insufficiency. The study sample will consist of evaluable patients, all of whom will be children younger than 7 years of age. Patients will receive Eurand PEP Microtabs formulation. The study design involves a 14-day screening period, a 7-day dose-stabilization period, and a 7-day treatment period (including an end-of-study evaluation).
The optimal dose of Eurand PEP Microtabs, determined during the dose-stabilization period, will be used during the treatment period. Patients were instructed to consume a predefined diet.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
University of Alabama
Published on BioPortfolio: 2014-07-23T21:12:43-0400
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A chloride channel that regulates secretion in many exocrine tissues. Abnormalities in the CFTR gene have been shown to cause cystic fibrosis. (Hum Genet 1994;93(4):364-8)
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