HealthyNCT00685477

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

A study testing Experimental Sequence ABC, Experimental Sequence ACB and Experimental Sequence BAC in people with Healthy, run by Temple University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Experimental Sequence ABC, Experimental Sequence ACB and Experimental Sequence BAC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: May 2008to Jul 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Temple University Hospital
Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Healthy
Being tested: Experimental Sequence ABC, Experimental Sequence ACB, Experimental Sequence BAC, Experimental Sequence BCA, Experimental Sequence CAB
Keywords: CCK infusion, Gallbladder ejection fraction, Normal volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Sequence ABCDrug
Also called Sequence ABC
Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes
Experimental Sequence ACBDrug
Also called Sequence ACB
Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes
Experimental Sequence BACDrug
Also called Sequence BAC
Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion
Experimental Sequence BCADrug
Also called Sequence BCA
Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion
Experimental Sequence CABDrug
Also called Sequence CAB
Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion
Experimental Sequence CBADrug
Also called Sequence CBA
Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion

Study groups in NCT00685477
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Experimental Sequence CBA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 15, 30, 45, and 60 minutes post drug infusion

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Jul 2009

First posted28 May 2008 (estimated)
Study startMay 2008
Primary completionMay 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00685477
Sponsor's protocol ID: CCK-2008
Status last verified: Dec 2016
First submitted: 22 May 2008
Last updated: 17 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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. doi: 10.1053/j.gastro.2005.11.063.
PubMed 16678563
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.
PubMed 20080900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying
ClinicalTrials.gov ID: NCT00685477
Acronym / sponsor ID: CCK-2008
Conditions: Healthy
Keywords: CCK infusion, Gallbladder ejection fraction, Normal volunteers
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: Johns Hopkins University, Penn State University, Memorial Health University Medical Center
Study start: May 2008
Primary completion: May 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 28 May 2008 (estimated)
Results: Posted 17 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects had 3 infusion studies at least 2 days apart within 3 weeks.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Experimental Sequence ABC	Active comparator	Drug: Experimental Sequence ABCCCK-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
Experimental Sequence ACB	Active comparator	Drug: Experimental Sequence ACBCCK-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
Experimental Sequence BAC	Active comparator	Drug: Experimental Sequence BACCCK-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
Experimental Sequence BCA	Active comparator	Drug: Experimental Sequence BCACCK-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
Experimental Sequence CAB	Active comparator	Drug: Experimental Sequence CABCCK-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
Experimental Sequence CBA	Active comparator	Drug: Experimental Sequence CBACCK-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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental Sequence ABCAlso: Sequence ABCDrug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes	Drug	Experimental Sequence ABC
Experimental Sequence ACBAlso: Sequence ACBDrug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes	Drug	Experimental Sequence ACB
Experimental Sequence BACAlso: Sequence BACDrug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion	Drug	Experimental Sequence BAC
Experimental Sequence BCAAlso: Sequence BCADrug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion	Drug	Experimental Sequence BCA
Experimental Sequence CABAlso: Sequence CABDrug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion	Drug	Experimental Sequence CAB
Experimental Sequence CBAAlso: Sequence CBADrug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion	Drug	Experimental Sequence CBA

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 17 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Sequence ABC	10	10
Experimental Sequence ACB	10	10
Experimental Sequence BAC	10	10
Experimental Sequence BCA	10	10
Experimental Sequence CAB	10	10
Experimental Sequence CBA	10	10

Primary outcome: Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method

Time frame: 15, 30, 45, and 60 minutes post drug infusion. Number (95% Confidence Interval). Unit: percentage

Measure	15min Infusion n = 60	30 Min Infusion n = 60	60 Min Infusion n = 60
15 min post infusion	51.66 (43.79 to 63.01)	62.75 (53.19 to 76.53)	71.38 (60.52 to 87.08)
30 min post infusion	40.46 (33.49 to 51.10)	34.49 (29.23 to 42.06)	35.81 (30.36 to 43.69)
45 min post infusion	39.91 (33.05 to 50.42)	31.30 (25.91 to 39.53)	24.00 (20.35 to 29.28)
60 min post infusion	35.21 (29.15 to 44.48)	29.11 (24.10 to 36.77)	18.55 (15.73 to 22.64)

Population analysed: Some participants were excluded from analyses due to location testing procedures

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 15 min, 30 min, 45 min, and 60 min post-infusion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16678563Behar 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.
Results publication: PubMed 20080900Ziessman 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alan H Maurer, MD principal investigator

Temple University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Sequence ABC, Experimental Sequence ACB and Experimental Sequence BAC in people with Healthy, run by Temple University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method (time frame: 15, 30, 45, and 60 minutes post drug infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685477, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.