At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency
In Brief
A Phase 3 clinical trial evaluating Viokase® 16, Placebo, and 2 other interventions for Exocrine Pancreatic Insufficiency and 2 related conditions. Completed, enrolled 50 participants across 18 sites in 4 countries.
Detailed 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).
Study Details
Timeline
Interventions
Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.
Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.
Patients on PPI during Screening will continue their usual PPI therapy throughout the study.
Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.