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

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ClinicalTrials.gov Identifier: NCT01142128
Recruitment Status : Terminated (Viokase was taken off market during study and remained off over a year.)
First Posted : June 11, 2010
Results First Posted : February 21, 2013
Last Update Posted : February 21, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : February 2009
Primary Completion Date : December 2011
Study Completion Date : March 2012


Arms and Interventions

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 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
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


Outcome Measures

Primary Outcome Measures :
  1. Reduction of Abdominal Pain for Participants Taking Nexium Alone. [ Time Frame: 4 months ]
    To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

  2. Reduction of Abdominal Pain for Participants Taking Placebo to Nexium [ Time Frame: 4 months ]
    To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

  3. Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium [ Time Frame: 4 months ]
    To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

  4. Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo. [ Time Frame: 4 months ]
    To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01142128     History of Changes
Other Study ID Numbers: D.9612.L00058
First Posted: June 11, 2010    Key Record Dates
Results First Posted: February 21, 2013
Last Update Posted: February 21, 2013
Last Verified: February 2013

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