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

NCT00744250 | Terminated Phase 4

• 2 other identifiers: GCRC-271208-0819
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Exocrine Pancreatic Insufficiency; Chronic Pancreatitis; Cystic Fibrosis

Keywords

Exocrine Pancreatic Insufficiency; Chronic Pancreatitis; Cystic fibrosis; Pancrelipase; Pancrecarb; Intraduodenal aspiration; Bioavailability

Outcome Measures

Primary Outcomes (1)

• Peak levels of three enzymes - lipase, amylase, and protease - each measured in U/ml will be outcomes

  Samples will be collected over two consecutive 3 hour study periods and sent for analysis

Study Arms (1)

1

OTHER

Pre-treatment vs. post-treatment- In the first phase, before administration of the capsules and liquid diet, baseline gastric and duodenal secretions will be aspirated via the oro-enteric tube. Subjects will get 5 placebo capsules at Time=0 given orally with the liquid Lundh diet. Pancreato-biliary and duodenal secretions in the duodenal region will be aspirated continuously over the first 20 min. Gastric and duodenal fluids will be aspirated from 20-180 min at specified time points. Following a rest of 1 hour, the same process will be repeated with the drug capsules. At the end of the study the catheter will be removed and patient will be offered a meal.

Drug: Pancrelipase

Interventions

Pancrelipase DRUG

PANCRECARB MS-16

Also known as: Pancrecarb®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Digestive Care, Inc.: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

UNC Healthcare

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis, Chronic; Cystic Fibrosis

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

• Lisa Gangarosa, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Kim Brouwer, PharmD, PhD

  UNC School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

US (1)