drugset / Trial / NCT01142128

Viokase 16, Viokase16 Plus Nexium and Nexium Alone

NCT01142128

Phase 1 Terminated 12 enrolled University of Florida AstraZeneca · collab
RandomizedCrossoverDouble-blindTreatment

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 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.

Timeline

Start
2009-02
Primary completion
2011-12
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 40 mg
Comparator Pancrelipase Protein / enzyme biologic

Indications