Viokase 16, Viokase16 Plus Nexium and Nexium Alone

NCT01142128 | Terminated Phase 1 Results

• 1 other identifier: D.9612.L00058
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (4)

Nexium alone

ACTIVE COMPARATOR

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)

Placebo to Nexium, alone

PLACEBO COMPARATOR

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

Viokase 16 (pancrelipase) + Nexium

ACTIVE COMPARATOR

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 + placebo to Nexium

PLACEBO COMPARATOR

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

Interventions

Nexium (esomeprazole magnesium) DRUG

one 40 mg capsule per day for one month

Also known as: Nexium

Nexium alone

Placebo to Nexium DRUG

one capsule per day for one month

Placebo to Nexium, alone

Viokase 16 (pancrelipase) + Nexium 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 (pancrelipase) + Nexium

Viokase 16 + placebo to Nexium 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

Viokase 16 + placebo to Nexium

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• History of abdominal pain associated with chronic pancreatitis
• 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

You may not qualify if:

• Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.
• Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.
• Female subjects who are pregnant or lactating
• Subject use of enzyme therapy other than that called for in this study
• Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.
• Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -

Sponsors & Collaborators

• University of Florida: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Esomeprazole; Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Results Point of Contact

• Title: Phillip Toskes, M.D.
• Organization: University of Florida

phillip.toskes@medicine.ufl.edu

352-273-9493

Study Officials

• Phillip P Toskes, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 11, 2010
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: February 21, 2013
• Results First Posted: February 21, 2013

Record last verified: 2013-02

Locations

US (1)