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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

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:

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 -

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

NCT ID

NCT01142128

First Posted

June 9, 2010

Last Updated

February 20, 2013

Sponsor

University of Florida

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01142128

Brief Title

Viokase 16, Viokase16 Plus Nexium and Nexium Alone

Acronym

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

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

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

Learn more about this trial

Viokase 16, Viokase16 Plus Nexium and Nexium Alone

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