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.
Trial 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. Read more about this study
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Penn State University, Memorial Health University Medical Center
- Responsible party
- Principal investigator, Alan Maurer, Temple University
- Investigators
- Alan H Maurer, MD, Principal investigator, Temple University
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 16678563Ziessman 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
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.
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.
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
- 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
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.