Pediatric Hypothalamic Obesity

NCT ID: NCT00076362

Last Updated: 2011-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo.

To qualify for this study, you and your child's doctor must feel that your child's weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child's weight.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Sandostatin LAR

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Patients with severe neurologic handicaps which preclude normal physical activity will be excluded.
* Patients confined to bed and those patients who are wheelchair bound which prevents them from activities of daily living or normal physical activity, i.e. walking, will be excluded from the trial
* Your child must be greater than 120% of their ideal body weight for their height or have a body mass index that is greater than or equal to 27.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Phoenix Children'S Hospital

Phoenix, Arizona, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

University of California at San Francisco

San Francisco, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Miami Children'S Hopital

Miami, Florida, United States

Site Status

Childrens Memorial Hospital

Chicago, Illinois, United States

Site Status

St. Vincent Children's Center for Cancer and Blood Diseases

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

U of Tennessee HELP Center

Memphis, Tennessee, United States

Site Status

UT Southwestern Children's Medical Center of Dallas

Dallas, Texas, United States

Site Status

Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CSMS995B2403

Identifier Type: -

Identifier Source: org_study_id

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