Status:
TERMINATED
Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)
Lead Sponsor:
Digestive Care, Inc.
Collaborating Sponsors:
St. Louis University
Conditions:
Exocrine Pancreatic Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00749099
Start Date
April 1 2007
End Date
September 1 2010
Last Update
February 22 2013
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