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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

June 9, 2010
February 20, 2013
February 2009
December 2011   (final data collection date for primary outcome measure)
  • 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
Reduction of abdominal pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
To elucidate the role of Nexium in the control of pancreatic pain
Complete list of historical versions of study NCT01142128 on ClinicalTrials.gov Archive Site
Not Provided
  • Decreased pain medication usage [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Subject keeps diary of pain medication usage while on the 4 arms of the study
  • Decreased Emergency Room visits [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Subject keeps diary of ER visits during the 4 arms of the study
  • Decreased hospital admissions for abdominal pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Subject keeps diary of hospital admissions during the 4 arms of the study
Not Provided
Not Provided
 
Viokase 16, Viokase16 Plus Nexium and Nexium Alone
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Pancreatitis
  • Drug: Nexium (esomeprazole magnesium)
    one 40 mg capsule per day for one month
    Other Name: Nexium
  • Drug: Placebo to Nexium
    one capsule per day for one month
    Other Name: placebo to Nexium
  • 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
  • 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
  • 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
    Intervention: Drug: Nexium (esomeprazole magnesium)
  • 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
    Intervention: Drug: 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.
    Intervention: Drug: 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
    Intervention: Drug: Viokase 16 + placebo to Nexium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
March 2012
December 2011   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01142128
D.9612.L00058
No
University of Florida
University of Florida
AstraZeneca
Principal Investigator: Phillip P Toskes, M.D. University of Florida
University of Florida
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP