Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)
Information source: Digestive Care, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exocrine Pancreatic Insufficiency
Intervention: pancrelipase (Drug); placebo (Drug)
Sponsored by: Digestive Care, Inc.
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.
Official title: 092206: Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) From PANCRECARB® (Pancrelipase), Delayed Release Capsules, Buffered and Enteric-Coated Microspheres
Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Evidence of the bioavailability of lipase, amylase and protease in the upper intestine from exogenously administered PANCRECARBÂ® (pancrelipase), when taken with a Lundh test meal.
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 (PANCRECARBÂ® (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 PANCRECARBÂ® (pancrelipase): lipase, amylase and protease activities, pH
(bicarbonate), and protein fingerprinting by SDS-PAGE analysis.
Minimum age: 18 Years.
Maximum age: N/A.
- Documented chronic pancreatitis, alcohol induced chronic pancreatitis or cystic
- Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 <75
mcg/g stool at the time of inclusion in the study
- Required daily exogenous enzyme supplementation with commercially available
- > 18 years of age
- Male and female subjects qualify
- Able to swallow capsules
- Clinically stable with no evidence of an acute medical condition
- History of steatorrhea
- History of fibrosing colonopathy in CF subjects
- Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in
the past 4 months
- Known contraindication, sensitivity or hypersensitivity to porcine pancreatic enzymes
- Active liver disease
- ALT or AST >3 times the upper limit of normal
- Bilirubin >3 times the upper limit of normal
- Acute pancreatitis or acute exacerbation of chronic pancreatitis
- Acute treatment with any systemic (oral or IV) antibiotics two weeks prior to
- Subjects on erythromycin unwilling to discontinue the treatment two weeks prior to
- Receiving treatment with antacids or H2 receptor blockers or proton pump inhibitors
and unable to discontinue these treatments prior to day 1
- Inability to cooperate with or non-compliant with required study procedures
- Pregnant, breast feeding
- Current daily prescribed scheduled use of narcotics (patients requiring PRN use of
narcotics are not excluded)
- Poorly controlled diabetes
- A medical condition which the investigator deems significant enough to interfere with
the ability of the subject to participate in the intubation study or interfering with
assessment or enzyme bioavailability
- Stomach pH > 4
- Small bowel disease (i. e. celiac disease)
Locations and Contacts
Starting date: April 2007
Last updated: February 20, 2013