drugset / Trial / 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

NCT00414908

Phase 3 Completed 52 enrolled Solvay Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-10
Primary completion
2008-08
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 24000 iu