NCT00749099

Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)

092206: Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) From PANCRECARB® (Pancrelipase), Delayed Release Capsules, Buffered and Enteric-Coated Microspheres

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Digestive Care, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal.

Detailed description

Eligible patients for this placebo-controlled study had confirmed exocrine pancreatic insufficiency with a stool pancreatic elastase of \<75 mcg/g. Patients who satisfied all inclusion criteria are prepared for endoscopic placement of three Liguory nasal biliary aspiration catheters: one 8.5 fr. catheter in the distal duodenum for aspiration, one 7.0 fr. catheter in the first portion of the duodenum for infusion of a PEG marker (4 mL/min) and one 7.0 fr. in the stomach for aspiration. Baseline samples are obtained from the gastric and distal duodenal ports and placed on ice. Subjects are then asked to swallow 5 capsules of a placebo (Phase I) or the test drug (PANCRECARB® (pancrelipase) - Phase II) with a standardized Lundh meal. Gastric samples are collected once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). All collected samples were tested for the following parameters to demonstrate bioavailability of enzymes originating from PANCRECARB® (pancrelipase): lipase, amylase and protease activities, pH (bicarbonate), and protein fingerprinting by SDS-PAGE analysis.

Conditions

• Exocrine Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	pancrelipase	The test drug (PANCRECARB® \[pancrelipase\] - Phase II) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each).
DRUG	placebo	5 capsules of a placebo drug (Phase I) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each).

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-09-09
• Last updated: 2013-02-22