Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Penn State University | OTHER |
| Memorial Health University Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
This study enrolled 60 healthy volunteers from four institutions (Johns Hopkins University, Pennsylvania State University, Memorial Health University Medical Center, and Temple University. Subjects had to be healthy men or women 18-65 years old with no gastrointestinal disease as confirmed by initial screening using a modified Mayo Clinic Research Gastrointestinal Disease Screening Questionnaire, and normal results for CBC, metabolic profile, serum amylase and gallbladder ultrasonography. Women could not be enrolled if pregnant.
Subjects had 3 infusion studies at least 2 days apart within 3 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Sequence ABC | Active Comparator | CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg 60 minutes, with at least 2 days between each infusion |
|
| Experimental Sequence ACB | Active Comparator | CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg 30 minutes, with at least 2 days between each infusion |
|
| Experimental Sequence BAC | Active Comparator | CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg 60 minutes, with at least 2 days between each infusion |
|
| Experimental Sequence BCA | Active Comparator | CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg 15 minutes, with at least 2 days between each infusion |
|
| Experimental Sequence CAB | Active Comparator | CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg 30 minutes, with at least 2 days between each infusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Sequence ABC | Drug | Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values. | 15, 30, 45, and 60 minutes post drug infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 15, 30, 45 and 60 minutes post-infusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan H Maurer, MD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678563 | Background | Behar J, Corazziari E, Guelrud M, Hogan W, Sherman S, Toouli J. Functional gallbladder and sphincter of oddi disorders. Gastroenterology. 2006 Apr;130(5):1498-509. doi: 10.1053/j.gastro.2005.11.063. | |
| 20080900 | Result | Ziessman HA, Tulchinsky M, Lavely WC, Gaughan JP, Allen TW, Maru A, Parkman HP, Maurer AH. Sincalide-stimulated cholescintigraphy: a multicenter investigation to determine optimal infusion methodology and gallbladder ejection fraction normal values. J Nucl Med. 2010 Feb;51(2):277-81. doi: 10.2967/jnumed.109.069393. Epub 2010 Jan 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Sequence ABC | Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes |
| FG001 | Experimental Sequence ACB | Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes |
| FG002 | Experimental Sequence BAC | Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes |
| FG003 | Experimental Sequence BCA | Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes |
| FG004 | Experimental Sequence CAB | Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes |
| FG005 | Experimental Sequence CBA | Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Each of the 60 subjects had 3 infusion studies at least 2 days apart.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values. | Some participants were excluded from analyses due to location testing procedures | Posted | Number | 95% Confidence Interval | percentage | 15, 30, 45, and 60 minutes post drug infusion |
|
15 min, 30 min, 45 min, and 60 min post-infusion
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 | All Study Participants | Drug given over 15 minute infusion to look at lowest coefficient of variation in infusion, followed by infusion over 30 minutes, followed by infusion over 60 minutes |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Maurer, MD | Temple University | 215-707-8269 | amaurer@temple.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Experimental Sequence CBA | Active Comparator | CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg 15 minutes, with at least 2 days between each infusion |
|
|
| Experimental Sequence ACB | Drug | Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes |
|
|
| Experimental Sequence BAC | Drug | Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion |
|
|
| Experimental Sequence BCA | Drug | Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion |
|
|
| Experimental Sequence CAB | Drug | Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion |
|
|
| Experimental Sequence CBA | Drug | Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion |
|
|
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 30 Min Infusion |
Drug given over 30 minutes infusion |
| OG002 | 60 Min Infusion | Drug given over 60 minutes infusion |
|
|
| Secondary | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | Some participants were excluded from analyses due to location testing procedures | Posted | Mean | Standard Deviation | percentage | 15, 30, 45 and 60 minutes post-infusion |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
Not provided
Not provided
| 30 minutes post-infusion |
|
|
| 45 minutes post-infusion |
|
|
| 60 minutes post-infusion |
|
|