Viokase 16, Viokase16 Plus Nexium and Nexium Alone (AZ)

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

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 Overview

• Status: Terminated
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Drug: Nexium (esomeprazole magnesium); Drug: Placebo to Nexium; Drug: Viokase 16 (pancrelipase) + Nexium; Drug: Viokase 16 + placebo to Nexium

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (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 (PPI)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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nexium alone; Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium	Drug: Nexium (esomeprazole magnesium); one 40 mg capsule per day for one month; Other Names: Nexium
Placebo Comparator: Placebo to Nexium, alone; Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium	Drug: Placebo to Nexium; one capsule per day for one month
Active Comparator: 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 (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
Placebo Comparator: Viokase 16 + placebo to Nexium; Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Abdominal Pain for Participants Taking Nexium Alone.	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months
Reduction of Abdominal Pain for Participants Taking Placebo to Nexium	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Phillip P Toskes, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): February 21, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole; Pancrelipase; Pancreatin
• Other Study ID Numbers: D.9612.L00058