AzTrials
AzTrials

BulimiaPhase 2GSKNCT00600743

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

A Phase 2 study testing GSKI181771X (CCK-1R agonist), Instructions to binge eat and Instructions to eat normally in people with Bulimia, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Bulimia
What is being tested?
GSKI181771X (CCK-1R agonist), Instructions to binge eat and Instructions to eat normally
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Jan 2008to Feb 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Both controls and patients will be female, 18 to 45 years old, and within 80-120% of ideal body weight (Metropolitan Life Insurance, 1983). Inclusion and exclusion will be evaluated using the following guidelines:
  • Normal Controls:
  • No current or past psychiatric illness
  • No history of binge eating or vomiting
  • 80-120% ideal weight
  • Of non-childbearing potential (i.e. physiologically incapable of becoming pregnant or surgically sterile)
Show all 12Show fewer
  • If of childbearing potential, willing to use an acceptable method of birth-control (please see list in "Exclusion" section)
  • Patients with Bulimia Nervosa:
  • DSM-IV (diagnostic statistical manual - American Psychiatric Association) criteria for bulimia nervosa
  • Duration of illness > 1 year
  • Purging after binges via self-induced vomiting
  • (Same as controls for remaining inclusion criteria)

Who cannot join

  • Normal Controls:
  • Significant medical illness: CBC, Chem-1, serum electrolytes (sodium, potassium, chloride, CO2), glucose, BUN (blood urea nitrogen), creatinine, Alk Phos, ALT (SGPT), AST (SGOT), LDH, total bilirubin, total protein, albumin, globulin, A/G ratio, calcium, phosphorus, uric acid, cholesterol, triglyceride
  • ALT outside of upper limit of normal: Chem-1
  • History of gallstones, pancreatitis or cholecystitis
  • Current medication
  • Hypersensitivity to benzodiazepines (contraindication in DCSI v02, 1-March-2006)
Show all 16Show fewer
  • Drug or alcohol abuse in last 3 mts
  • Pregnancy
  • Unable or unwilling to use highly effective methods of contraception for the duration of the study until an insignificant amount of the investigational product remains in the subject (i.e. at least 5 terminal phase half-lives). Examples of highly effective methods of contraception are:
  • Implants of levonorgestrel, or
  • Injectable progestogen, or
  • Oral birth control pills for at least 3 monthly cycles prior to administration of study drug + continuation for 24 hrs after last dose of study drug, or
  • Double-barrier method (e.g. condom, diaphragm) with spermicide
  • Note-Significant medical illness is any illness requiring continued care, i.e. chronic medication. Examples include hypertension, diabetes, and systemic lupus erythematosis. Subjects with seasonal allergies or occasional urinary tract infections will be included.
  • Patients with Bulimia Nervosa:
  • Same as controls

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Luke's/Roosevelt Hospital

    New York, New York, 10025

Other trials in United States

About this study

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.

Read the detailed description

This study tests the hypothesis that an oral CCK antagonist GSKI181771X will reduce the size of a binge meal. It was intended to study the effects of increasing doses on antagonist on normal individuals to find an effective dose in a non-binge meal before moving to a binge meal. Once the effects of the antagonist on a binge meal were found, the compound would be used on patients with bulimia nervosa. However, the product expired and more was not available before the patients were tested. Data are presented for the normal participants who were instructed to eat normally, followed by a group that was instructed to binge eat. Comparisons were made between groups with different instructions and between binge and normal meals.

Conditions
Bulimia
Being tested
GSKI181771X (CCK-1R agonist), Instructions to binge eat, Instructions to eat normally, Placebo
Keywords
Eating, Food Intake, Appetite
Medical subject headings
Bulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSKI181771X (CCK-1R agonist)Drug

    Also called GSKI181771X

    Drug one trial vs placebo

  • Instructions to binge eatBehavioural

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

  • Instructions to eat normallyBehavioural

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

  • PlaceboDrug

    Drug one trial vs placebo

Study groups in NCT00600743
Study groupRoleWhat they receive
1 'Instructions to eat normally'Placebo comparator'Instructions to eat normally' Placebo 1 mg dose
Receives: Behavioral: Instructions to eat normally; Drug: Placebo
2 'Instructions to eat normally'Active comparator'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)'
Receives: Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to eat normally
3 'Instructions to eat normally'Placebo comparator'Instructions to eat normally' 2 mg placebo
Receives: Behavioral: Instructions to eat normally; Drug: Placebo
4 'Instructions to eat normally'Active comparator'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)'
Receives: Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to eat normally
5 'Instructions to eat normally'Placebo comparator'Instructions to eat normally' 4 mg placebo
Receives: Behavioral: Instructions to eat normally; Drug: Placebo
6 'Instructions to eat normally'Active comparator'Instructions to eat normally' 4 mg drug 'GSKI181771X (CCK-1R agonist)'
Receives: Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to eat normally
7 Instructions to binge eatPlacebo comparatorInstructions to binge eat 4 mg placebo
Receives: Behavioral: Instructions to binge eat; Drug: Placebo
8 Instructions to binge eatActive comparatorInstructions to binge eat 4 mg drug 'GSKI181771X (CCK-1R agonist)'
Receives: Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to binge eat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions

    Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions

    Measured: 25-30 min after taking drug

Secondary outcomes (2)

  1. Fullness Rating

    rating of "How full do you feel" by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable).

    Measured: 25-30 min after taking drug

  2. Sickness Report

    Response to question "How sick do you feel" measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)

    Measured: 25-30 min after drug or placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Why it stopped: Drug expired before was completed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600743
Sponsor's protocol ID
07-101
Acronym
GSK
Status last verified
Apr 2017
First submitted
14 Jan 2008
Last updated
28 Apr 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSKI181771X (CCK-1R agonist), Instructions to binge eat and Instructions to eat normally in people with Bulimia, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions (time frame: 25-30 min after taking drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00600743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in