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

NCT00744250 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2013-02-22

No results posted yet for this study

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

Interventions

DRUG

Pancrelipase

PANCRECARB MS-16

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • Digestive Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Gangarosa, M.D. · University of North Carolina, Chapel Hill

  • Kim Brouwer, PharmD, PhD · UNC School of Pharmacy

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00744250 on ClinicalTrials.gov