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

This study has been terminated.
(No longer required study by FDA for NDA approval.)
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Digestive Care, Inc.
ClinicalTrials.gov Identifier:
NCT00744250
First received: August 28, 2008
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Exocrine Pancreatic Insufficiency
Chronic Pancreatitis
Cystic Fibrosis
Drug: Pancrelipase
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency

Resource links provided by NLM:


Further study details as provided by Digestive Care, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1

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
PANCRECARB MS-16
Other Name: Pancrecarb®

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 placebo control in patients with pancreatic insufficiency. Lipase, amylase and protease activities will be determined from stomach and duodenal aspirates after standard meal stimulation.

Participants:

Patients with pancreatic insufficiency will be recruited as the study population.

Procedures (methods):

Eligible subjects will undergo an initial screening phase and will provide a stool sample to confirm pancreatic exocrine insufficiency based on a spot fecal elastase-1 of < 75 mcg/g stool. Within one month after the screening phase, subjects meeting inclusion criteria will be scheduled to arrive in the GCRC by 7pm. If the subject is a female of child bearing age, a serum pregnancy test will be checked. At 7am the subject will be escorted to fluoroscopy for placement of an oro-enteric tube. Once the tip of the tube has been positioned in the duodenum, the subject will be escorted back to the GCRC. Prior to administration of the capsules and liquid diet, baseline gastric and duodenal secretions will be aspirated via the oro-enteric tube by the investigators. Subjects will then receive 5 capsules of active drug with a standard liquid Lundh diet of 360 mL over a 10 minute period, administered to simulate a fed state. Then duodenal and gastric secretions will be aspirated from the tube over a 3-hour period. At the end of the 3 hours, the subject will be allowed to rest for 60 minutes. The second phase will consist of 5 capsules of placebo again with a standard liquid Lundh diet , and another 3-hour aspiration phase. After the second 3-hour aspiration period, the balloon will be deflated and the tube will be removed. Subjects will be observed for 30 minutes and then discharged.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744250

Locations
United States, North Carolina
UNC Healthcare
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Digestive Care, Inc.
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Lisa Gangarosa, M.D. University of North Carolina, Chapel Hill
Principal Investigator: Kim Brouwer, PharmD, PhD UNC School of Pharmacy
  More Information

No publications provided

Responsible Party: Digestive Care, Inc.
ClinicalTrials.gov Identifier: NCT00744250     History of Changes
Other Study ID Numbers: GCRC-2712, 08-0819
Study First Received: August 28, 2008
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Digestive Care, Inc.:
Exocrine Pancreatic Insufficiency
Chronic Pancreatitis
Cystic fibrosis
Pancrelipase
Pancrecarb
Intraduodenal aspiration
Bioavailability

Additional relevant MeSH terms:
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014