PR-018: An Open-Label, Safety Extension of Study PR-011

Status Completed

Clinical Trial Summary

A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

Clinical Trial Description

This is a multi-center, open-label, safety extension of Aptalis (formerly Eurand) study PR-011 (NCT01100606) in pediatric participants with EPI due to CF. The study will be carried out in participants who completed the PR-011 study.

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, participants will be enrolled into the study. ;

Study Design

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

Related Conditions & MeSH terms

Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis

Clinical Trial Details

NCT number	NCT01131507
Study type	Interventional
Source	Forest Laboratories
Contact
Status	Completed
Phase	Phase 4
Start date	July 2010
Completion date	December 2011

View Details

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