NCT00690820

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

A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.

Conditions

• Cystic Fibrosis
• Pancreatic Exocrine Insufficiency

Interventions

Type	Name	Description
DRUG	Pancrelipase Delayed Release	12,000 unit Capsules, dosed individually based on fat intake.
DRUG	Placebo Comparator	Placebo

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-06-05
• Last updated: 2010-06-02
• Results posted: 2010-03-10

Locations

10 sites across 1 country: United States