Overview

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

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forest Laboratories
Treatments:
Pancreatin
Pancrelipase
Criteria
Inclusion Criteria:

- Participant's parent or guardian signed informed consent form (ICF)

- Participants who have completed study PR-011 (NCT01100606)

Exclusion Criteria:

- Participant having any condition that would, in the investigator's opinion, limit the
participant's ability to complete the study or will result in excess risk to the
participant that is above the standard of care