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
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
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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