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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00744250
Date of registration: 28/08/2008
Prospective Registration: No
Primary sponsor: Digestive Care, Inc.
Public title: Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control
Scientific title: Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency
Date of first enrolment: August 2008
Target sample size: 3
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00744250
Study type:  Interventional
Study design:  Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Kim Brouwer, PharmD, PhD
Address: 
Telephone:
Email:
Affiliation:  UNC School of Pharmacy
Name:     Lisa Gangarosa, M.D.
Address: 
Telephone:
Email:
Affiliation:  University of North Carolina, Chapel Hill
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Intervention(s)
Drug: Pancrelipase
Primary Outcome(s)
Peak levels of three enzymes - lipase, amylase, and protease - each measured in U/ml will be outcomes [Time Frame: Samples will be collected over two consecutive 3 hour study periods and sent for analysis]
Secondary Outcome(s)
Secondary ID(s)
GCRC-2712
08-0819
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of North Carolina, Chapel Hill
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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