Chronic Pancreatitis
Conditions
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.
Interventions
DRUGNexium (esomeprazole magnesium)
one 40 mg capsule per day for one month
DRUGPlacebo to Nexium
one capsule per day for one month
DRUGViokase 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
DRUGViokase 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
Sponsors
AstraZeneca
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
The dates of the recruitment period were February 2009 through January 2010. Subjects recruited at the University of Florida and the Shands Hospital. Recruited a total of 12 subjects. Enrollment was slow due to subjects not wanting to come off their medications, this was unanticipated.
Pre-assignment details
A total of 12 participants were consented to the study, however, 4 participants were never randomized to the study. Prior to randomization, subjects were off all enzymes and proton pump inhibitor's (PPI's) for 14 days.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| 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 | 3 |
| Viokase 16 Plus Nexium Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium | 2 |
| Viokase 16 Plus 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 | 0 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Total | Viokase 16 Plus Nexium | Nexium Alone | Placebo to Nexium, Alone |
|---|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 1 participants | 0 participants | 0 participants | 1 participants |
| Age Categorical Between 18 and 65 years | 7 participants | 2 participants | 3 participants | 2 participants |
| Gender Female | 4 participants | 1 participants | 1 participants | 2 participants |
| Gender Male | 4 participants | 1 participants | 2 participants | 1 participants |
| Region of Enrollment United States | 8 participants | 2 participants | 3 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 3 | 0 / 3 | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 1 / 3 | 0 / 2 | 0 / 0 |
Outcome results
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
Time frame: 4 months
Population: Analysis was not able to be done due to the small sample size.
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
Time frame: 4 months
Population: Analysis was not able to be done due to the small sample size.
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
Time frame: 4 months
Population: Analysis was not able to be done due to the small sample size.
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
Time frame: 4 months
Population: Analysis was not able to be done due to the small sample size.