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

NCT ID: NCT00749099

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-09-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Phase I

All subject participate in Phase I

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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).

Phase II

All subject participate in Phase II

Group Type: ACTIVE_COMPARATOR

pancrelipase

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

PANCRECARB®

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: collaborator

Digestive Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB #14687

Identifier Type: -

Identifier Source: secondary_id

DCI092206

Identifier Type: -

Identifier Source: org_study_id