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