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

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Brief Title

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

Official Title

Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency

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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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


Condition

Exocrine Pancreatic Insufficiency

Intervention

Pancrelipase

Study Arms / Comparison Groups

 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3

Start Date

August 2008

Completion Date

May 2010

Primary Completion Date

May 2010

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lisa Gangarosa, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00744250

Organization ID

GCRC-2712

Secondary IDs

08-0819

Responsible Party

Sponsor

Study Sponsor

Digestive Care, Inc.

Collaborators

 University of North Carolina, Chapel Hill

Study Sponsor

Lisa Gangarosa, M.D., Principal Investigator, University of North Carolina, Chapel Hill


Verification Date

February 2013