An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI. The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects with CP suffering from EPI.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI).|
- Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
No Intervention: 1
Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion.
The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure.
Drug: VIOKASE 16
The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.
Day of screening: Subjects will undergo screening procedures prior to entry into the study.
Day 0: Subjects will be admitted to the facility. Day 1: Subjects will undergo a first perfusion/aspiration procedure. Day 2: Subjects will rest. Day 3: Subjects will undergo a second perfusion/aspiration procedure. Day 4: Subjects will be discharged.
|United States, Florida|
|Shands Hospital, University of Florida|
|Gainesville, Florida, United States, 32610|
|United States, Minnesota|
|Santhi Swaroop Vege, M.D.|
|Mayo Clinic- Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Phillip P. Toskes, M.D.||University of Florida|