Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The following are the study hypothesis:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChiRhoStim | Active Comparator | Human Secretin for Injection |
|
| Placebo | Placebo Comparator | Saline for Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChiRhoStim | Drug | Human Secretin for Injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Sample | Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8). (Note- The outcome value is boolean (yes or no) as an answer). | First 5 minutes after treatment administration |
| Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid. | First 5 minutes after treatment administration |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Burton, M.D. | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | St Louis | Missouri | 63110 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ChiRhoStim | Human Secretin for Injection 0.1 mL/kg IV |
| FG001 | Placebo | Saline for Injection 0.1 mL/kg IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Saline for Injection |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ChiRhoStim | Human Secretin for Injection 0.1 mL/kg IV |
| BG001 | Placebo | Saline for Injection 0.1 mL/kg IV |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The demographic data represents the intent to treat group when data was provided in cases where no demographic data was provided for a parameter, the number of observations was correspondenly reduced. | Count of Participants | Participants |
| |||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Endoscopic Sample | Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8). (Note- The outcome value is boolean (yes or no) as an answer). | Not Posted | First 5 minutes after treatment administration | ||||||||||||||||||||||||||||||||||||||||||
| Primary | Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid. | Posted | Number | Participants | First 5 minutes after treatment administration |
|
|
|
Not provided
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 | ChiRhoStim | Human Secretin for Injection 0.1 mL/kg IV | 0 | 30 | 0 | 30 | ||
| EG001 | Placebo | Saline for Injection 0.1 mL/kg IV | 0 | 34 | 0 | 34 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Purich, Ph.D. | ChiRhoClin, Inc. | 301-476-8388 | mdoerr@chirhoclin.com |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|