Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to learn about the activity of oral Pancrecarb® (a pancreatic enzyme preparation which contains proteins that help to digest food), administered by mouth as a capsule filled with specially coated granules in patients taking exogenous pancreatic enzyme therapy. Specific enzymes activities will be determined from samples of stomach and intestinal fluids after a standard liquid meal.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Digestive Care, Inc.
• Collaborator: University of North Carolina, Chapel Hill
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 (<75 mcg/g) at the time of screening

• Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes

• ≥ 18 years of age

• Male and female subjects

• Able to swallow capsules

• Clinically stable with no evidence of an acute medical conditions

Exclusion Criteria:

• History of fibrosing colonopathy in cystic fibrosis subjects

• Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months

• Known contraindications, sensitivity or hypersensitivity to porcine pancreatic enzymes, benzocaine or similar products

• Women with a positive serum beta-hCG at the time of screening or the day of the study (due to radiation exposure)

• Liver disease

• ALT or AST ≥ 3 time the upper limit of normal

• Bilirubin ≥ 3 times the upper limit of normal

• Acute pancreatitis or acute exacerbation of chronic pancreatitis within 90 days

• Use of medications which affect with intestinal transit (example, narcotics, erythromycin, metoclopramide etc.)

• Subjects receiving treatment with antacids, H2 receptor blockers, or proton pump inhibitors and unable to discontinue these within 72 hr prior to the study day

• Diabetes mellitus

• A medical condition which the investigator deems significant enough to interfere with the ability of the subject to participate in the intubation study or interfere with the assessment of enzyme bioavailability

• Small bowel disease (i.e. celiac disease)

• Lactose intolerance

• History of gastric resection