Viokase 16, Viokase16 Plus Nexium and Nexium Alone

Chronic Pancreatitis Clinical Trial

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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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01142128
• Other study ID #: D.9612.L00058
• Status: Terminated
• Phase: Phase 1
• First received: June 9, 2010
• Last updated: February 20, 2013
• Start date: February 2009
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Nexium (esomeprazole magnesium)
one 40 mg capsule per day for one month
• Placebo to Nexium
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
• 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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Abdominal Pain for Participants Taking Nexium Alone.	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months	No
Primary	Reduction of Abdominal Pain for Participants Taking Placebo to Nexium	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months	No
Primary	Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months	No
Primary	Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain	4 months	No