Status:
TERMINATED
Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control
Lead Sponsor:
Digestive Care, Inc.
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Conditions:
Exocrine Pancreatic Insufficiency
Chronic Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 cap...
Detailed Description
Purpose: The purpose of this study is to assess the bioavailability of oral Pancrecarb® (exogenous pancreatic enzyme administered orally as a capsule filled with enteric coated granules) compared to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00744250
Start Date
August 1 2008
End Date
May 1 2010
Last Update
February 22 2013
Active Locations (1)
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1
UNC Healthcare
Chapel Hill, North Carolina, United States, 27599