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

This study is currently recruiting participants.

Verified by Temple University, October 2008

First Received: May 22, 2008 Last Updated: October 22, 2008 History of Changes

Sponsor:	Temple University
Collaborators:	Johns Hopkins University Penn State University Memorial Health University Medical Center
Information provided by:	Temple University
ClinicalTrials.gov Identifier:	NCT00685477

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:	Diagnostic, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacokinetics Study
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
C: Active Comparator Drug will be given over 60 minutes	Drug: CCK-8 0.02 mg/kg Drug will be given over 60 min infusion
A: Active Comparator Drug given over 15 minutes	Drug: CCK-8 0.02mg/kg Drug will be given over 15
B: Active Comparator 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:

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
Subjects with high probability for compliance and completion of the study
Normal liver function tests and amylase
Normal ultrasound of the gallbladder

Exclusion Criteria:

Prior GI surgery, excluding appendectomy
Surgery within the past 3 months
BMI > 35
Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
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.
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:

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.

Responsible Party:	Temple University School of Medicine ( Alan Maurer, MD )
Study ID Numbers:	CCK-2008
Study First Received:	May 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00685477 History of Changes
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 November 27, 2009