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

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00685477
• Collaborator: Johns Hopkins University (Other), Penn State University (Other), Memorial Health University Medical Center (Other)
• Enrollment: 60
• Location: 1
• Arms: 6
• Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Experimental Sequence ABC; Drug: Experimental Sequence ACB; Drug: Experimental Sequence BAC; Drug: Experimental Sequence BCA; Drug: Experimental Sequence CAB; Drug: Experimental Sequence CBA	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Experimental Sequence ABC; Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes; Other Names: Sequence ABC
Active Comparator: 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	Drug: Experimental Sequence ACB; Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes; Other Names: Sequence ACB
Active Comparator: 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	Drug: Experimental Sequence BAC; Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion; Other Names: Sequence BAC
Active Comparator: 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	Drug: Experimental Sequence BCA; Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion; Other Names: Sequence BCA
Active Comparator: 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	Drug: Experimental Sequence CAB; Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion; Other Names: Sequence CAB
Active Comparator: 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	Drug: Experimental Sequence CBA; Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion; Other Names: Sequence CBA

Outcome Measures

Primary Outcome Measures

1. Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method [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 Outcome Measures

1. Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method [15, 30, 45 and 60 minutes post-infusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Temple University Hospital	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

Study Documents (Full-Text)

None provided.

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: Alan Maurer, Professor of Medicine, Temple University
• ClinicalTrials.gov Identifier: NCT00685477
• Other Study ID Numbers: CCK-2008
• First Posted: May 28, 2008
• Last Update Posted: Feb 17, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Alan Maurer, Professor of Medicine, Temple University: CCK infusion; Gallbladder ejection fraction; Normal volunteers

Study Results

Participant Flow

Arm/Group Title	Experimental Sequence ABC	Experimental Sequence ACB	Experimental Sequence BAC	Experimental Sequence BCA	Experimental Sequence CAB	Experimental Sequence CBA
Arm/Group Description	Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes	Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes	Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes	Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes	Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes	Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes
Period Title: Overall Study
STARTED	10	10	10	10	10	10
COMPLETED	10	10	10	10	10	10
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments.
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38 (12)
Gender (Count of Participants)
Female	32 53.3%
Male	28 46.7%
Region of Enrollment (participants) [Number]
United States	60 100%

Outcome Measures

1. Primary Outcome

Title	Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method
Description	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.
Time Frame	15, 30, 45, and 60 minutes post drug infusion

Outcome Measure Data

Analysis Population Description

Some participants were excluded from analyses due to location testing procedures

Arm/Group Title	15min Infusion	30 Min Infusion	60 Min Infusion
Arm/Group Description	Drug given over 15 minutes infusion	Drug given over 30 minutes infusion	Drug given over 60 minutes infusion
Measure Participants	60	60	60
15 min post infusion	51.66	62.75	71.38
30 min post infusion	40.46	34.49	35.81
45 min post infusion	39.91	31.30	24.00
60 min post infusion	35.21	29.11	18.55

2. Secondary Outcome

Title	Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method
Time Frame	15, 30, 45 and 60 minutes post-infusion

Outcome Measure Data

Analysis Population Description

Some participants were excluded from analyses due to location testing procedures

Arm/Group Title	15 Minute Infusion	30 Minute Infusion	60 Minute Infusion
Arm/Group Description	Drug given over 15 minutes	Drug given over 30 minutes	Drug given over 60 minutes
Measure Participants	60	60	60
15 minutes post-infusion	57 (29)	44 (28)	34 (24)
30 minutes post-infusion	67 (27)	71 (24)	64 (23)
45 minutes post-infusion	66 (26)	73 (23)	78 (19)
60 minutes post-infusion	68 (24)	74 (21)	84 (16)

Adverse Events

Time Frame	15 min, 30 min, 45 min, and 60 min post-infusion
Arm/Group Title	All Study Participants
Arm/Group Description	Drug given over 15 minute infusion to look at lowest coefficient of variation in infusion, followed by infusion over 30 minutes, followed by infusion over 60 minutes
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/60 (0%)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.