NCT00414908

A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.

Conditions

• Chronic Pancreatitis
• Pancreatectomy
• Pancreatic Exocrine Insufficiency

Interventions

Type	Name	Description
DRUG	Pancrelipase delayed release capsule	24,000 unit capsule
DRUG	Placebo Comparator	Placebo

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-08-01
• Completion: 2009-12-01
• First posted: 2006-12-22
• Last updated: 2011-08-10
• Results posted: 2009-09-16

Locations

30 sites across 8 countries: United States, Bulgaria, Poland, Puerto Rico, Russia, Serbia, South Africa, Ukraine