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An Open Label,Safety Extension of Eurand Study PR-011

2014-07-23 21:08:57 | BioPortfolio

Summary

A Study to determine long term safety of EUR-1008 3,000 lipase units capsules (the "EUR-1008"), a Pancreatic Enzyme Product ("PEP"), in infants with CF who need to take PEP medications to help break down the food that they eat.

Description

Multi-center, Open-Label, Safety Extension of Eurand Study PR-011 in pediatric subjects with EPI associated with CF. The study will be carried out in infants greater than 1 month of age.

The study is comprised of 5 visits: an Enrollment Visit, Treatment Visit 1(3 months), Treatment Visit 2(6 months),Treatment Visit 3(9 months), and Treatment Visit 4(12 months). Once determined eligible for participation, subjects will be enrolled into the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

EUR-1008 3,000

Location

University of California, San Francisco Pediatrics
San Francisco
California
United States
94107

Status

Not yet recruiting

Source

Eurand S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:57-0400

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Medical and Biotech [MESH] Definitions

An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.

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Intestinal obstruction caused by congealed MECONIUM in the distal ILEUM and CECUM. It presents shortly after birth as a failure to pass meconium and frequently occurs in infants with CYSTIC FIBROSIS.

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