NCT00663975

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

An Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic Insufficiency

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Digestive Care, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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).

Conditions

• Digestive System Diseases
• Pancreatic Disease
• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	DCI 1020	capsules (4,000 units of lipase) will be administered with meals and snacks

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-11-01
• First posted: 2008-04-22
• Last updated: 2010-05-13

Locations

1 site across 1 country: United States