Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying

Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Experimental Sequence ABC; Drug: Experimental Sequence ACB; Drug: Experimental Sequence BAC; Drug: Experimental Sequence BCA; Drug: Experimental Sequence CAB; Drug: Experimental Sequence CBA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males and females between ages 18-65 years of age with no gastrointestinal disease as screened by the Mayo Clinic GI Disease Screening Questionnaire
2. Subjects with high probability for compliance and completion of the study
3. Normal liver function tests and amylase
4. Normal ultrasound of the gallbladder

Exclusion Criteria:

1. Prior GI surgery, excluding appendectomy
2. Surgery within the past 3 months
3. BMI > 35
4. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
5. Cardiovascular, endocrine, renal, gastrointestinal, or other chronic disease likely to affect motility. This includes diabetes, renal insufficiency, gastroesophageal reflux disease, gastroparesis, irritable bowel syndrome, prior peptic ulcer disease.
6. GI symptoms such as heartburn, chest pain, dysphagia, abdominal pain, nausea, vomiting, constipation, diarrhea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental Sequence ABC; 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	Drug: Experimental Sequence ABC; Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes; Other Names: Sequence ABC
Active Comparator: Experimental Sequence ACB; 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	Drug: Experimental Sequence ACB; Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes; Other Names: Sequence ACB
Active Comparator: Experimental Sequence BAC; 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	Drug: Experimental Sequence BAC; Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion; Other Names: Sequence BAC
Active Comparator: Experimental Sequence BCA; 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	Drug: Experimental Sequence BCA; Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion; Other Names: Sequence BCA
Active Comparator: Experimental Sequence CAB; 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	Drug: Experimental Sequence CAB; Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion; Other Names: Sequence CAB
Active Comparator: Experimental Sequence CBA; 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	Drug: Experimental Sequence CBA; Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion; Other Names: Sequence CBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method	15, 30, 45 and 60 minutes post-infusion

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Johns Hopkins University; Penn State University; Memorial Health University Medical Center
• Investigators: Principal Investigator: Alan H Maurer, MD, Temple University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Normal volunteers; CCK infusion; Gallbladder ejection fraction
• Other Study ID Numbers: CCK-2008