NCT01142128

Viokase 16, Viokase16 Plus Nexium and Nexium Alone

A Randomized, Single Site, Double Blind, Fixed Dose, Cross Over Study of Viokase 16, Viokase16 Plus Nexium and Nexium Alone in the Reduction of Abdominal Pain in Patients With Chronic Pancreatitis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	Nexium (esomeprazole magnesium)	one 40 mg capsule per day for one month
DRUG	Placebo to Nexium	one capsule per day for one month
DRUG	Viokase 16 (pancrelipase) + Nexium	Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month
DRUG	Viokase 16 + placebo to Nexium	Viokase 16 pancrelipase tablets are given per day for one month with one capsule of placebo to esomeprazole magnesium, one per day for one month

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2010-06-11
• Last updated: 2013-02-21
• Results posted: 2013-02-21

Locations

1 site across 1 country: United States