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

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.

Conditions

• Healthy

Interventions

DRUG

Experimental Sequence ABC

Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes

DRUG

Experimental Sequence ACB

Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes

DRUG

Experimental Sequence BAC

Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion

DRUG

Experimental Sequence BCA

Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion

DRUG

Experimental Sequence CAB

Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion

DRUG

Experimental Sequence CBA

Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• Memorial Health University Medical Center

  collaborator OTHER

• Temple University

  lead OTHER

Principal Investigators

• Alan H Maurer, MD · Temple University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2009-05-31

Completion

2009-07-31

Countries

• United States

Study Locations