Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) - Full Text View

Sponsored by:	Digestive Care, Inc.
Information provided by:	Digestive Care, Inc.
ClinicalTrials.gov Identifier:	NCT00749099

Purpose

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.

Condition	Intervention
Exocrine Pancreatic Insufficiency	Drug: pancrelipase Drug: placebo

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Bio-availability Study
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

Further study details as provided by Digestive Care, Inc.:

Primary Outcome Measures:

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. [ Time Frame: 4 hours post administration of PANCRECARB® and or Placebo ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	April 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase I: Placebo Comparator 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).
Phase II: Active Comparator 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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749099

Contacts

Contact: Frank Burton, MD

314-577-8764

burtonfr@slu.edu

Locations

United States, Missouri
Saint Louis University	Recruiting
St. Louis, Missouri, United States, 63104
Principal Investigator: Frank Burton, MD

Sponsors and Collaborators

Digestive Care, Inc.

Investigators

Principal Investigator:

Frank Burton, MD

St. Louis University

More Information

Responsible Party:	Saint Louis University ( Frank Burton, M.D. )
Study ID Numbers:	DCI092206, IRB #14687
Study First Received:	September 7, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00749099
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Pancreatic Diseases
Pancrelipase
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009