Viokase 16, Viokase16 Plus Nexium and Nexium Alone

Phase 1

Terminated

• Conditions: Chronic Pancreatitis
• Interventions: Drug: Nexium (esomeprazole magnesium); Drug: Placebo to Nexium; Drug: Viokase 16 (pancrelipase) + Nexium; Drug: Viokase 16 + placebo to Nexium

• Registration Number: NCT01142128
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Results First Submitted: 2012-10-19
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-20
• Last Update Submitted: 2013-02-20
• Results First Posted: 2013-02-21
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nexium alone	Nexium (esomeprazole magnesium)	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
Placebo to Nexium, alone	Placebo to Nexium	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
Viokase 16 (pancrelipase) + Nexium	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 + 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

Primary Outcome Measures

Name	Time	Method
Reduction of Abdominal Pain for Participants Taking Nexium Alone.	4 months	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	4 months	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	4 months	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.	4 months	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States