An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559052
|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|