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A Study to Evaluate the Mode of Administration in Infants Less Than 12 Months of EUR-1008

2014-08-27 03:14:40 | BioPortfolio

Summary

A Study to determine the safety, effectiveness, and acceptability of 2 methods of administration 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

Multicenter, randomized, open-label, crossover study in pediatric subjects with EPI associated with CF. The study will be carried out in infants between 1 and 12 months of age.

The study is comprised of 1 screening period followed by 2 treatment periods and a follow-up visit. During the Screening Period, all subjects will be administered ZENPEP®. Once determined eligible for participation, subjects will be randomized to 1 of 2 treatment groups, and administered treatment with 1 of 2 different methods of administration.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

Syringe nurser

Location

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

Status

Recruiting

Source

Eurand S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:40-0400

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