Clinical trial NCT00685477
Conditions: Healthy
Keywords: CCK infusion Gallbladder ejection fraction Normal volunteers
Sponsor: Temple University
Start date: 2008-05-01; Completion date: 2009-07-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

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.

Arms: arm 1: 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 arm 2: 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 arm 3: 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 arm 4: 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 arm 5: 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 arm 6: 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
Interventions: intervention 1: Experimental Sequence ABC intervention 2: Experimental Sequence ACB intervention 3: Experimental Sequence BAC intervention 4: Experimental Sequence BCA intervention 5: Experimental Sequence CAB intervention 6: Experimental Sequence CBA
Intervention descriptions: intervention 1: Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes intervention 2: Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes intervention 3: Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion intervention 4: Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion intervention 5: Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion intervention 6: Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion

Protocol documents: