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

NCT00749099 | Terminated DMC

• 2 other identifiers: DCI092206IRB #14687
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Phase I

PLACEBO COMPARATOR

All subject participate in Phase I

Drug: placebo

Phase II

ACTIVE COMPARATOR

All subject participate in Phase II

Drug: pancrelipase

Interventions

pancrelipase 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).

Also known as: PANCRECARB®

Phase II

placebo 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 I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented chronic pancreatitis, alcohol induced chronic pancreatitis or cystic fibrosis
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Digestive Care, Inc.: lead
• St. Louis University: collaborator

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2008
• First Posted: September 9, 2008
• Study Start: April 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 22, 2013

Record last verified: 2013-02