drugset / Trial / NCT01131507

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

NCT01131507

Phase 4 Completed 15 enrolled Forest Laboratories
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2010-07
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 3000 iu Oral