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| Name | Class |
|---|---|
| Dartmouth-Hitchcock Medical Center | OTHER |
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12 patients will be enrolled in this study. Patients will be only those treated at Dartmouth-Hitchcock Medical Center for the diagnosis of CP. The diagnosis of CP will be made by the PI based on standard clinical, radiographic and/or biochemical criteria. Patients must be taking prescribed opioid analgesics for the specific treatment of CP at the time of study enrollment. Only patients between the ages of 18-70 and capable of providing informed consent will be considered eligible for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human secretin | Other | intravenous secretin administration in escalating doses three times daily for three days. After each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Secretin | Drug | Dose Escalation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30. | 10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day. | Baseline, Days 1, 2, 3, 4, 7, 30. |
| Opiate Use at Baseline, Days 4 and 30. | Daily opiate use (oral morphine equivalent). | Baseline, Day 4, Day 30. |
| Quality of Life at Baseline, Day 4 and Day 30. | Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes. | Baseline, Day 4, Day 30. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events. | 30 Days | |
| VAS Score at Each Administered Dose. | 10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy B Gardner, M.D. | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23548879 | Derived | Levenick JM, Andrews CL, Purich ED, Gordon SR, Gardner TB. A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. Pancreas. 2013 May;42(4):596-600. doi: 10.1097/MPA.0b013e318273f3ec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Secretin | Human Secretin : Dose Escalation There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Human Secretin | Human Secretin : Dose Escalation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30. | 10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 1, 2, 3, 4, 7, 30. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Human Secretin | Human Secretin : Dose Escalation within participant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Central line infection (coagulase negative S. Aureus infection with bacteremia) | Infections and infestations | Non-systematic Assessment | Previous Hx central line infections. The SAE was related to a PICC line positioned in the R subclavian vein to provide the patient with TPN required by a Dx of CP related to alcohol abuse. Only subject in study with central line so only one at risk. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea, mild | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Gardner, MD | Dartmouth-Hitchcock Medical Center | 603-650-6472 | timothy.b.gardner@hitchcock.org |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D012633 | Secretin |
| ID | Term |
|---|---|
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
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| Days 1, 2, and 3. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events. | Posted | Number | participants | 30 Days |
|
|
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| Primary | Opiate Use at Baseline, Days 4 and 30. | Daily opiate use (oral morphine equivalent). | Posted | Mean | Standard Deviation | mg/day | Baseline, Day 4, Day 30. |
|
|
|
|
| Primary | Quality of Life at Baseline, Day 4 and Day 30. | Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 4, Day 30. |
|
|
|
| Secondary | VAS Score at Each Administered Dose. | 10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3. | Posted | Mean | Standard Deviation | units on a scale | Days 1, 2, and 3. |
|
|
|
| 3 |
| 12 |
| 9 |
| 12 |
|
| Pain, nausea, vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| epigastrium and right upper quadrant pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| mild flushing, upper body | Vascular disorders | Non-systematic Assessment | Flushing is listed as a side effect in the package insert for human secretin. |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
|
| .34 |
| 2-Sided |
| No |
| Superiority or Other |
|
| Title |
|---|
| Measurements |
|---|
|
| .2 mcg/kg |
|
| .4 mcg/kg |
|
| .8 mcg/kg |
|