Viokase 16, Viokase16 Plus Nexium and Nexium Alone
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Intervention: Nexium (esomeprazole magnesium); Placebo to Nexium; Viokase 16 (pancrelipase) + Nexium; Viokase 16 + placebo to Nexium
Intervention description: one 40 mg capsule per day for one month; one capsule per day for one month; 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 pancrelipase tablets are given per day for one month with one capsule of placebo to esomeprazole magnesium, one per day for one month
Intervention MeSH terms: Esomeprazole; Pancrelipase; Pancreatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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 -