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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Johns Hopkins University
Penn State University
Memorial Health University Medical Center
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00685477
First received: May 22, 2008
Last updated: October 22, 2008
Last verified: October 2008
History of Changes
  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: CCK-8 0.02mg/kg
Drug: CCK-8 0.02 mg/kg

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

Resource links provided by NLM:

Drug Information available for: Sincalide
U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Normal gallbladder ejection fraction [ Time Frame: 15 minutes, 30 minutes and 60 minutes post drug infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: C
Drug will be given over 60 minutes
 Drug: CCK-8 0.02 mg/kg
Drug will be given over 60 min infusion
Active Comparator: A
Drug given over 15 minutes
 Drug: CCK-8 0.02mg/kg
Drug will be given over 15
Active Comparator: B
Drug given over 30 minutes
 Drug: CCK-8 0.02 mg/kg
Drug infused over 30 min

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685477

Contacts
Contact: Alan H Maurer, MD 215-707-8269 amaurer@temple.edu

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
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, MD, Temple University School of Medicine
ClinicalTrials.gov Identifier: NCT00685477     History of Changes
Other Study ID Numbers: CCK-2008
Study First Received: May 22, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 13, 2013