Cystic Fibrosis Clinical Trial
Official title:
An Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic Insufficiency
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).
A large body of data supporting the safety and efficacy of PANCRECARB® (pancrelipase)
Capsules is available in patients above age 2. This study is being performed to gather the
data to demonstrate the safety and efficacy of DCI1020 in pediatric CF patients (≤ 2 years)
with exocrine pancreatic insufficiency. This study also takes into consideration an "age
appropriate" dosing form. Specifically, the enzymes will be administered orally by opening
the capsules and emptying the microspheres into a small amount of applesauce as an example
of a slightly acidic soft food such as jelly, jello, etc. for feeding.
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(pancrelipase).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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