Status:

COMPLETED

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

Lead Sponsor:

Temple University

Collaborating Sponsors:

Johns Hopkins University

Penn State University

Conditions:

Healthy

Eligibility:

All Genders

18-65 years

Phase:

NA

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 s...

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 ha...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2009

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00685477

Start Date

May 1 2008

End Date

July 1 2009

Last Update

February 17 2017

Active Locations (1)

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1

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140