Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying
Information source: Temple University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: CCK-8 0.02mg/kg (Drug); CCK-8 0.02 mg/kg (Drug); CCK-8 0.02 mg/kg (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Temple University Official(s) and/or principal investigator(s):
Alan H Maurer, MD, Principal Investigator, Affiliation: Temple University
Overall contact:
Alan H Maurer, MD, Phone: 215-707-8269, Email: amaurer@temple.edu
Summary
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.
Clinical Details
Official title: Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying
Study design: Diagnostic, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Normal gallbladder ejection fraction
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Alan H Maurer, MD, Phone: 215-707-8269, Email: amaurer@temple.edu
Temple University Hospital, Philadelphia, Pennsylvania 19140, United States; Recruiting
Additional Information
Related 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. Review.
Starting date: May 2008
Last updated: October 22, 2008
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