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Viokase 16, Viokase16 Plus Nexium and Nexium Alone

2014-07-24 14:01:02 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Chronic Pancreatitis

Intervention

Nexium (esomeprazole magnesium), Placebo to Nexium, Viokase 16 (pancrelipase) plus Nexium (esomeprazole magnesium), Viokase 16 (pancrelipase) plus placebo to Nexium (esomeprazole magnesium)

Location

University of Florida
Gainesville
Florida
United States
32610

Status

Recruiting

Source

University of Florida

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:02-0400

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Medical and Biotech [MESH] Definitions

Magnesium chloride. An inorganic compound consisting of one magnesium and two chloride ions. The compound is used in medicine as a source of magnesium ions, which are essential for many cellular activities. It has also been used as a cathartic and in alloys.

Magnesium oxide (MgO). An inorganic compound that occurs in nature as the mineral periclase. In aqueous media combines quickly with water to form magnesium hydroxide. It is used as an antacid and mild laxative and has many nonmedicinal uses.

A nutritional condition produced by a deficiency of magnesium in the diet, characterized by anorexia, nausea, vomiting, lethargy, and weakness. Symptoms are paresthesias, muscle cramps, irritability, decreased attention span, and mental confusion, possibly requiring months to appear. Deficiency of body magnesium can exist even when serum values are normal. In addition, magnesium deficiency may be organ-selective, since certain tissues become deficient before others. (Harrison's Principles of Internal Medicine, 12th ed, p1936)

The S-isomer of omeprazole.

Inorganic compounds that contain magnesium as an integral part of the molecule.

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