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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Sequence ABC

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

Group Type ACTIVE_COMPARATOR

Experimental Sequence ABC

Intervention Type DRUG

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

Experimental Sequence ACB

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

Group Type ACTIVE_COMPARATOR

Experimental Sequence ACB

Intervention Type DRUG

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

Experimental Sequence BAC

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

Group Type ACTIVE_COMPARATOR

Experimental Sequence BAC

Intervention Type DRUG

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

Experimental Sequence BCA

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

Group Type ACTIVE_COMPARATOR

Experimental Sequence BCA

Intervention Type DRUG

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

Experimental Sequence CAB

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

Group Type ACTIVE_COMPARATOR

Experimental Sequence CAB

Intervention Type DRUG

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

Experimental Sequence CBA

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

Group Type ACTIVE_COMPARATOR

Experimental Sequence CBA

Intervention Type DRUG

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

Interventions

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Experimental Sequence ABC

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

Intervention Type DRUG

Experimental Sequence ACB

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

Intervention Type DRUG

Experimental Sequence BAC

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

Intervention Type DRUG

Experimental Sequence BCA

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

Intervention Type DRUG

Experimental Sequence CAB

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

Intervention Type DRUG

Experimental Sequence CBA

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

Intervention Type DRUG

Other Intervention Names

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Sequence ABC Sequence ACB Sequence BAC Sequence BCA Sequence CAB Sequence CBA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes