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Sponsored by: |
Digestive Care, Inc. |
---|---|
Information provided by: | Digestive Care, Inc. |
ClinicalTrials.gov Identifier: | NCT00749099 |
The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal.
Condition | Intervention |
---|---|
Exocrine Pancreatic Insufficiency |
Drug: pancrelipase Drug: placebo |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Bio-availability Study |
Official Title: | 092206: Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) From PANCRECARB® (Pancrelipase), Delayed Release Capsules, Buffered and Enteric-Coated Microspheres |
Estimated Enrollment: | 10 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Phase I: Placebo Comparator
All subject participate in Phase I
|
Drug: placebo
5 capsules of a placebo drug (Phase I) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). |
Phase II: Active Comparator
All subject participate in Phase II
|
Drug: pancrelipase
The test drug (PANCRECARB® [pancrelipase] - Phase II) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). |
Eligible patients for this placebo-controlled study had confirmed exocrine pancreatic insufficiency with a stool pancreatic elastase of <75 mcg/g. Patients who satisfied all inclusion criteria are prepared for endoscopic placement of three Liguory nasal biliary aspiration catheters: one 8.5 fr. catheter in the distal duodenum for aspiration, one 7.0 fr. catheter in the first portion of the duodenum for infusion of a PEG marker (4 mL/min) and one 7.0 fr. in the stomach for aspiration. Baseline samples are obtained from the gastric and distal duodenal ports and placed on ice. Subjects are then asked to swallow 5 capsules of a placebo (Phase I) or the test drug (PANCRECARB® (pancrelipase) - Phase II) with a standardized Lundh meal. Gastric samples are collected once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). All collected samples were tested for the following parameters to demonstrate bioavailability of enzymes originating from PANCRECARB® (pancrelipase): lipase, amylase and protease activities, pH (bicarbonate), and protein fingerprinting by SDS-PAGE analysis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Frank Burton, MD | 314-577-8764 | burtonfr@slu.edu |
United States, Missouri | |
Saint Louis University | Recruiting |
St. Louis, Missouri, United States, 63104 | |
Principal Investigator: Frank Burton, MD |
Principal Investigator: | Frank Burton, MD | St. Louis University |
Responsible Party: | Saint Louis University ( Frank Burton, M.D. ) |
Study ID Numbers: | DCI092206, IRB #14687 |
Study First Received: | September 7, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00749099 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Pancreatic Diseases Pancrelipase Exocrine Pancreatic Insufficiency |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |