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Viokase 16, Viokase16 Plus Nexium and Nexium Alone

Information source: University of Florida
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pancreatitis

Intervention: Nexium (esomeprazole magnesium) (Drug); Placebo to Nexium (Drug); Viokase 16 (pancrelipase) plus Nexium (esomeprazole magnesium) (Drug); Viokase 16 (pancrelipase) plus placebo to Nexium (esomeprazole magnesium) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Phillip P Toskes, M.D., Principal Investigator, Affiliation: University of Florida

Overall contact:
Phillip P Toskes, M.D., Phone: 352-273-9493, Email: toskepp@medicine.ufl.edu

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.

Clinical Details

Official title: 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

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

Primary outcome: Reduction of abdominal pain

Secondary outcome:

Decreased pain medication usage

Decreased Emergency Room visits

Decreased hospital admissions for abdominal pain

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. 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.

2. History of abdominal pain associated with chronic pancreatitis

3. 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 ERCP, or diffuse changes on EUS, fecal elastase > 100ug/g stool, or serum trypsinogen > 20ng/ml

-

Exclusion Criteria:

1. Subjects on enzyme therapy within the last 14 days, proton pump inhibitor within the last 7 days, or octreotide within 48 hours.

2. Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.

3. Female subjects who are pregnant or lactating

4. Subject use of enzyme therapy other than that called for in this study

5. Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.

6. Past history of documented steatorrhea by 72 hour fecal fat determination or current

history consistent with steatorrhea -

Locations and Contacts

Phillip P Toskes, M.D., Phone: 352-273-9493, Email: toskepp@medicine.ufl.edu

University of Florida, Gainesville, Florida 32610, United States; Recruiting
Phillip P Toskes, M.D., Phone: 352-273-9493, Email: toskepp@medicine.ufl.edu
Cheryl L Curington, B.S., Phone: 352-392-6293, Email: curincl@medicine.ufl.edu
Philllip P Toskes, M.D., Principal Investigator
Additional Information

Starting date: February 2009
Last updated: September 16, 2011

Page last updated: December 08, 2011

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