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Effect of a CCK-1R Agonist on Food Intake in Humans

NCT00600743 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-04-28

Study results available
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Summary

The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (CCK) agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia Nervosa. The study will be conducted in phases. First, an effective dose for reducing food intake, when normal subjects eat normally will be attained. Next, it will be determined whether intake at this dose is reduced in control subjects instructed to eat to capacity. If the dose is still effective compared to placebo, the same dose will be tested in patients with bulimia nervosa.

Conditions

  • Bulimia

Interventions

DRUG

GSKI181771X (CCK-1R agonist)

Drug one trial vs placebo

BEHAVIORAL

Instructions to binge eat

Subjects will be instructed to binge eat and will also be given either drug or placebo

BEHAVIORAL

Instructions to eat normally

Subjects will be instructed to eat normally and will also be given either drug or placebo

DRUG

Placebo

Drug one trial vs placebo

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • St. Luke's-Roosevelt Hospital Center

    lead OTHER

Principal Investigators

  • Harry R. Kissileff, Ph.D. · St. Luke's-Roosevelt Hospital Center

  • Jeanine Albu, MD · St. Luke's-Roosevelt Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00600743 on ClinicalTrials.gov