Not provided
Not provided
Not provided
Not provided
Viokase was taken off market during study and remained off over a year.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexium (esomeprazole magnesium) | Drug | one 40 mg capsule per day for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
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
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Phillip P Toskes, M.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received one of four interventions in a randomized crossover design:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo to Nexium, Alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Analysis was not able to be done due to the small sample size. | Posted | 4 months |
|
|
Adverse events were collected from 03/02/2009 until 08/15/2010
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Pain | Gastrointestinal disorders | MedDra 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Liver Enzymes | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Toskes, M.D. | University of Florida | 352-273-9493 | phillip.toskes@medicine.ufl.edu |
Not provided
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo to Nexium | Drug | one capsule per day for one month |
|
| 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 + 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 |
|
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
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| 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 | Analysis was not able to be done due to the small sample size. | Posted | 4 months |
|
|
| 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 | Analysis was not able to be done due to the small sample size. | Posted | 4 months |
|
|
| 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 | Analysis was not able to be done due to the small sample size. | Posted | 4 months |
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 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 | 1 | 3 | 0 | 3 |
| EG002 | 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 | 0 | 2 | 0 | 2 |
| EG003 | 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 | 0 | 0 | 0 |
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |