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

This study has been terminated.
(Viokase was taken off market during study and remained off over a year.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01142128
First received: June 9, 2010
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Chronic Pancreatitis
Drug: Nexium (esomeprazole magnesium)
Drug: Placebo to Nexium
Drug: Viokase 16 (pancrelipase) + Nexium
Drug: Viokase 16 + placebo to Nexium
Phase 1

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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Reduction of Abdominal Pain for Participants Taking Nexium Alone. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain


Enrollment: 12
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Other Name: placebo to Nexium
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
Other Name: Viokase 16 (pancrelipase) + Nexium
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
Other Name: Viokase 16 + placebo to Nexium

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142128

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
AstraZeneca
Investigators
Principal Investigator: Phillip P Toskes, M.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01142128     History of Changes
Other Study ID Numbers: D.9612.L00058
Study First Received: June 9, 2010
Results First Received: October 19, 2012
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pancreatin
Pancrelipase
Esomeprazole
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014