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

Primary Purpose

Chronic Pancreatitis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nexium (esomeprazole magnesium)
Placebo to Nexium
Viokase 16 (pancrelipase) + Nexium
Viokase 16 + placebo to Nexium
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Nexium alone

Placebo to Nexium, alone

Viokase 16 (pancrelipase) + Nexium

Viokase 16 + placebo to Nexium

Arm Description

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

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

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.

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

Outcomes

Primary Outcome Measures

Reduction of Abdominal Pain for Participants Taking Nexium Alone.
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 9, 2010
Last Updated
February 20, 2013
Sponsor
University of Florida
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01142128
Brief Title
Viokase 16, Viokase16 Plus Nexium and Nexium Alone
Acronym
AZ
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Viokase was taken off market during study and remained off over a year.
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nexium alone
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo to Nexium, alone
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Viokase 16 (pancrelipase) + Nexium
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Viokase 16 + placebo to Nexium
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nexium (esomeprazole magnesium)
Other Intervention Name(s)
Nexium
Intervention Description
one 40 mg capsule per day for one month
Intervention Type
Drug
Intervention Name(s)
Placebo to Nexium
Intervention Description
one capsule per day for one month
Intervention Type
Drug
Intervention Name(s)
Viokase 16 (pancrelipase) + Nexium
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Viokase 16 + placebo to Nexium
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction of Abdominal Pain for Participants Taking Nexium Alone.
Description
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame
4 months
Title
Reduction of Abdominal Pain for Participants Taking Placebo to Nexium
Description
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame
4 months
Title
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium
Description
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame
4 months
Title
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.
Description
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. History of abdominal pain associated with chronic pancreatitis 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: Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours. Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes. Female subjects who are pregnant or lactating Subject use of enzyme therapy other than that called for in this study Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study. Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip P Toskes, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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Viokase 16, Viokase16 Plus Nexium and Nexium Alone

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