Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control
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.
Exocrine Pancreatic Insufficiency
|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|
- 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 ]
|Study Start Date:||August 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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.
Other Name: Pancrecarb®
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.
Patients with pancreatic insufficiency will be recruited as the study population.
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.
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Lisa Gangarosa, M.D.||University of North Carolina, Chapel Hill|
|Principal Investigator:||Kim Brouwer, PharmD, PhD||UNC School of Pharmacy|