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

University of Florida

Status and phase: Terminated; Phase 1

Conditions: Chronic Pancreatitis

Treatments: Drug: Viokase 16 + placebo to Nexium; Drug: Nexium (esomeprazole magnesium); Drug: Viokase 16 (pancrelipase) + Nexium; Drug: Placebo to Nexium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01142128

D.9612.L00058

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 4 patient groups, including a placebo group

Nexium alone

Active Comparator group

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

Treatment:

Drug: Nexium (esomeprazole magnesium)

Placebo to Nexium, alone

Placebo Comparator group

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

Treatment:

Drug: Placebo to Nexium

Viokase 16 (pancrelipase) + Nexium

Active Comparator group

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.

Treatment:

Drug: Viokase 16 (pancrelipase) + Nexium

Viokase 16 + placebo to Nexium

Placebo Comparator group

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

Treatment:

Drug: Viokase 16 + placebo to Nexium