Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
Status:
Withdrawn
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic
insufficiency in CF patients <= 2 years of age.
The results of this study are intended to be submitted to the FDA as part of the NDA package
for marketing approval of PANCRECARB (DCI 1020).