Viokase 16, Viokase16 Plus Nexium and Nexium Alone

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Nexium (esomeprazole magnesium)

Intervention Type DRUG

one 40 mg capsule per day for one month

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

Group Type PLACEBO_COMPARATOR

Placebo to Nexium

Intervention Type DRUG

one capsule per day for one month

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.

Group Type ACTIVE_COMPARATOR

Viokase 16 (pancrelipase) + Nexium

Intervention Type DRUG

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 + 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

Group Type PLACEBO_COMPARATOR

Viokase 16 + placebo to Nexium

Intervention Type DRUG

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

Interventions

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Nexium (esomeprazole magnesium)

one 40 mg capsule per day for one month

Intervention Type DRUG

Placebo to Nexium

one capsule per day for one month

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No