NCT00510484

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

A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Pancrelipase Delayed Release	24000 unit Capsule
DRUG	Placebo Comparator	Placebo

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-08-02
• Last updated: 2010-06-03
• Results posted: 2009-07-20

Locations

23 sites across 5 countries: United States, Hungary, Israel, South Africa, Spain