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

Stopped early · Phase 4

Conditions studied: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00744250

Run by

Digestive Care, Inc.

People needed

3

Starts

2008-08-01

Expected to finish

2010-05-01

Last updated by the study team

2013-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UNC Healthcare — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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