N/A
N=60
Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00685477 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method — 51.66; 62.75; 71.38; 40.46 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Sequence ABC (Drug); Experimental Sequence ACB (Drug); Experimental Sequence BAC (Drug); Experimental Sequence BCA (Drug); Experimental Sequence CAB (Drug); Experimental Sequence CBA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method |
51.66; 62.75; 71.38; 40.46; 34.49; 35.81 | — |
| SECONDARY Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method |
57; 44; 34; 67; 71; 64 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00685477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.