NCT00775528

Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 1 Month – 6 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

Conditions

• Cystic Fibrosis
• Pancreatic Exocrine Insufficiency

Interventions

Type	Name	Description
DRUG	Pancrelipase Delayed Release	3,000, 6,000 and 12,000 unit Lipase Capsules

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-10-20
• Last updated: 2010-11-08
• Results posted: 2010-10-01

Locations

12 sites across 1 country: United States