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

This study has been terminated.
(No longer required study by FDA for NDA approval.)
Sponsor:
Collaborator:
St. Louis University
Information provided by (Responsible Party):
Digestive Care, Inc.
ClinicalTrials.gov Identifier:
NCT00749099
First received: September 7, 2008
Last updated: February 20, 2013
Last verified: February 2013

September 7, 2008
February 20, 2013
April 2007
September 2010   (final data collection date for primary outcome measure)
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. [ Time Frame: 4 hours post administration of PANCRECARB® and or Placebo ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00749099 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)
092206: Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) From PANCRECARB® (Pancrelipase), Delayed Release Capsules, Buffered and Enteric-Coated Microspheres

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.

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 prepared for endoscopic placement of three Liguory nasal biliary aspiration catheters: one 8.5 fr. catheter in the distal duodenum for aspiration, one 7.0 fr. catheter in the first portion of the duodenum for infusion of a PEG marker (4 mL/min) and one 7.0 fr. in the stomach for aspiration. Baseline samples are obtained from the gastric and distal duodenal ports and placed on ice. Subjects are then asked to swallow 5 capsules of a placebo (Phase I) or the test drug (PANCRECARB® (pancrelipase) - Phase II) with a standardized Lundh meal. Gastric samples are collected once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). All collected samples were tested for the following parameters to demonstrate bioavailability of enzymes originating from PANCRECARB® (pancrelipase): lipase, amylase and protease activities, pH (bicarbonate), and protein fingerprinting by SDS-PAGE analysis.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Exocrine Pancreatic Insufficiency
  • Drug: pancrelipase

    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).

    Other Name: PANCRECARB®
  • Drug: placebo

    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).

  • Placebo Comparator: Phase I
    All subject participate in Phase I
    Intervention: Drug: placebo
  • Active Comparator: Phase II
    All subject participate in Phase II
    Intervention: Drug: pancrelipase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00749099
DCI092206, IRB #14687
Yes
Digestive Care, Inc.
Digestive Care, Inc.
St. Louis University
Not Provided
Digestive Care, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP