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

NCT00685477 | Completed Results

• 1 other identifier: CCK-2008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

CCK infusion; Gallbladder ejection fraction; Normal volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method

  15, 30, 45 and 60 minutes post-infusion

Study Arms (6)

Experimental Sequence ABC

ACTIVE COMPARATOR

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

Experimental Sequence ACB

ACTIVE COMPARATOR

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

Experimental Sequence BAC

ACTIVE COMPARATOR

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

Experimental Sequence BCA

ACTIVE COMPARATOR

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

Experimental Sequence CAB

ACTIVE COMPARATOR

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

Experimental Sequence CBA

ACTIVE COMPARATOR

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

Interventions

Experimental Sequence ABC DRUG

Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes

Also known as: Sequence ABC

Experimental Sequence ABC

Experimental Sequence ACB DRUG

Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes

Also known as: Sequence ACB

Experimental Sequence ACB

Experimental Sequence BAC DRUG

Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion

Also known as: Sequence BAC

Experimental Sequence BAC

Experimental Sequence BCA DRUG

Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion

Also known as: Sequence BCA

Experimental Sequence BCA

Experimental Sequence CAB DRUG

Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion

Also known as: Sequence CAB

Experimental Sequence CAB

Experimental Sequence CBA DRUG

Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion

Also known as: Sequence CBA

Experimental Sequence CBA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead
• Johns Hopkins University: collaborator
• Penn State University: collaborator
• Memorial Health University Medical Center: collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (2)

• 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.

  PMID: 16678563 BACKGROUND

• 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.

  PMID: 20080900 RESULT

Results Point of Contact

• Title: Alan Maurer, MD
• Organization: Temple University

amaurer@temple.edu

215-707-8269

Study Officials

• Alan H Maurer, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 28, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 17, 2017
• Results First Posted: February 17, 2017

Record last verified: 2016-12

Locations

US (1)