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

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.

Study Overview

• Status: Terminated
• Conditions: Exocrine Pancreatic Insufficiency
• Intervention / Treatment: Drug: placebo; Drug: pancrelipase

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented chronic pancreatitis, alcohol induced chronic pancreatitis or cystic fibrosis
• 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 pancreatic enzymes
• > 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

Exclusion Criteria:

• 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 screening
• Subjects on erythromycin unwilling to discontinue the treatment two weeks prior to screening
• 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)

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Phase I; All subject participate in Phase I	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).
Active Comparator: Phase II; All subject participate in Phase II	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).; Other Names: PANCRECARB®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evidence of the bioavailability of lipase, amylase and protease in the upper intestine from exogenously administered PANCRECARB® (pancrelipase), when taken with a Lundh test meal.	4 hours post administration of PANCRECARB® and or Placebo

Collaborators and Investigators

• Sponsor: Digestive Care, Inc.
• Collaborators: St. Louis University

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: September 7, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Exocrine Pancreatic Insufficiency; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: DCI092206; IRB #14687