Status:
TERMINATED
Viokase 16, Viokase16 Plus Nexium and Nexium Alone
Lead Sponsor:
University of Florida
Collaborating Sponsors:
AstraZeneca
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase ...
Eligibility Criteria
Inclusion
- Males and females age 18 to 75 years inclusive. Female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study.
- History of abdominal pain associated with chronic pancreatitis
- Evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal CT showing a dilated pancreatic duct and/or atrophy, an abnormal Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (EUS), fecal elastase \> 100ug/g stool, or serum trypsinogen \> 20ng/ml
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Exclusion
- Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.
- Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.
- Female subjects who are pregnant or lactating
- Subject use of enzyme therapy other than that called for in this study
- Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.
- Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01142128
Start Date
February 1 2009
End Date
March 1 2012
Last Update
February 21 2013
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610