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Completed

NCT Number: NCT00685477

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Sequence ABC

Drug

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

Other names: Sequence ABC

Experimental Sequence ACB

Drug

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

Other names: Sequence ACB

Experimental Sequence BAC

Drug

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

Other names: Sequence BAC

Experimental Sequence BCA

Drug

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

Other names: Sequence BCA

Experimental Sequence CAB

Drug

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

Other names: Sequence CAB

Experimental Sequence CBA

Drug

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

Other names: Sequence CBA

Primary outcomes

  1. 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 outcomes

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

    Time frame: 15, 30, 45 and 60 minutes post-infusion

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Johns Hopkins University
  • Memorial Health University Medical Center
  • Penn State University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 28, 2008
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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