An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00559052|
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : February 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Exocrine Pancreatic Insufficiency||Drug: VIOKASE 16||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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).|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
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.
- Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ]
- Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|