drugset
drugset / Trial / NCT00559364

Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

NCT00559364 ↗

Phase 3 Completed 50 enrolled Forest Laboratories
RandomizedParallel-groupDouble-blindTreatment

Summary

This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly Axcan).

Timeline

Start
2007-11
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject VIOKASE16 Protein / enzyme biologic — Oral
Background Omeprazole Other / unclassified 20 mg Oral

Indications

chronic pancreatitis exocrine pancreatic insufficiency