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

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Penn State University
Memorial Health University Medical Center
Information provided by (Responsible Party):
Alan Maurer, Temple University
ClinicalTrials.gov Identifier:
NCT00685477
First received: May 22, 2008
Last updated: December 28, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Healthy
Drug: Experimental Sequence ABC
Drug: Experimental Sequence ACB
Drug: Experimental Sequence BAC
Drug: Experimental Sequence BCA
Drug: Experimental Sequence CAB
Drug: Experimental Sequence CBA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Diagnostic
Official Title: Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method [ Time Frame: 15, 30, 45, and 60 minutes post drug infusion ]
    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.


Secondary Outcome Measures:
  • Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method [ Time Frame: 15, 30, 45 and 60 minutes post-infusion ]

Enrollment: 60
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685477

Locations
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Johns Hopkins University
Penn State University
Memorial Health University Medical Center
Investigators
Principal Investigator: Alan H Maurer, MD Temple University
  More Information

Publications:
Responsible Party: Alan Maurer, Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT00685477     History of Changes
Other Study ID Numbers: CCK-2008
Study First Received: May 22, 2008
Results First Received: December 28, 2016
Last Updated: December 28, 2016

Keywords provided by Temple University:
CCK infusion
Gallbladder ejection fraction
Normal volunteers

ClinicalTrials.gov processed this record on May 23, 2017