Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients

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).

Timeline

Start

2009-02

Primary completion

2009-08

Completion

2009-11

Drugs

Indications