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| Name | Class |
|---|---|
| AAIPharma | INDUSTRY |
| Mayo Clinical Services | UNKNOWN |
| City Hospital Laboratory Birmingham | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion. | |
| 2 | Experimental | The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIOKASE 16 | Drug | The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip P. Toskes, M.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Hospital, University of Florida | Gainesville | Florida | 32610 | United States | ||
| Santhi Swaroop Vege, M.D. |
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| Mayo Clinic- Rochester |
| Minnesota |
| 55905 |
| United States |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
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