NCT00076362

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 obesity

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2004

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

September 12, 2011

Status Verified

September 1, 2011

Enrollment Period

1.3 years

First QC Date

January 21, 2004

Last Update Submit

September 8, 2011

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in BMI

Secondary Outcomes (1)

  • Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat

Interventions

Sandostatin LARDRUG

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* Male and female patients ages 6 to less than 18 * Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it's treatment (i.e. surgery, radiation, and/or chemotherapy) * Patients who are at least one year out following therapy for their tumor * Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded * 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (15)

Phoenix Children'S Hospital

Phoenix, Arizona, 85016, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado

Denver, Colorado, 80218, United States

Location

Miami Children'S Hopital

Miami, Florida, 33155, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

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

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

U of Tennessee HELP Center

Memphis, Tennessee, 38103, United States

Location

UT Southwestern Children's Medical Center of Dallas

Dallas, Texas, 75390, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2004

First Posted

January 23, 2004

Study Start

March 1, 2004

Primary Completion

July 1, 2005

Last Updated

September 12, 2011

Record last verified: 2011-09

Locations

US(15)