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

• ClinicalTrials.gov Identifier: NCT01142128
• Recruitment Status: Terminated
• First Posted: June 11, 2010
• Results First Posted: February 21, 2013
• Last Update Posted: February 21, 2013
• Sponsor: University of Florida
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pancreatitis	Drug: Nexium (esomeprazole magnesium); Drug: Placebo to Nexium; Drug: Viokase 16 (pancrelipase) + Nexium; Drug: Viokase 16 + placebo to Nexium	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: February 2009
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	Drug: Nexium (esomeprazole magnesium); one 40 mg capsule per day for one month; Other Name: Nexium
Placebo Comparator: 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	Drug: Placebo to Nexium; one capsule per day for one month
Active Comparator: 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.	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
Placebo Comparator: 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	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

Outcome Measures

Primary Outcome Measures :

1. Reduction of Abdominal Pain for Participants Taking Nexium Alone. [ Time Frame: 4 months ]
   To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
2. Reduction of Abdominal Pain for Participants Taking Placebo to Nexium [ Time Frame: 4 months ]
   To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
3. Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium [ Time Frame: 4 months ]
   To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
4. Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo. [ Time Frame: 4 months ]
   To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

United States, Florida

University of Florida

Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

AstraZeneca

Investigators

• Principal Investigator: Phillip P Toskes, M.D.; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01142128
• Other Study ID Numbers: D.9612.L00058
• First Posted: June 11, 2010
• Results First Posted: February 21, 2013
• Last Update Posted: February 21, 2013
• Last Verified: February 2013

Additional relevant MeSH terms:

Pancreatitis; Pancreatitis, Chronic; Pancreatic Diseases; Digestive System Diseases; Esomeprazole; Pancrelipase; Pancreatin; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action