Pediatric Hypothalamic Obesity - Full Text View

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: Sandostatin LAR	Phase IV

MedlinePlus related topics:

Obesity Obesity in Children

Drug Information available for:

Octreotide Octreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in BMI

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076362

Locations


United States, Arizona
	Phoenix Children's Hospital
	PHOENIX, Arizona, United States, 85016

United States, California
	Children's Hospital of Orange County
	Orange, California, United States, 92868
	University of California at San Francisco
	San Francisco, California, United States, 94143

United States, Colorado
	University of Colorado
	Denver, Colorado, United States, 80218

United States, Florida
	Miami Children's Hopital
	Miami, Florida, United States, 33155

United States, Illinois
	Childrens Memorial Hospital
	Chicago, Illinois, United States, 60614

United States, Indiana
	St. Vincent Children's Center for Cancer and Blood Diseases
	Indianapolis, Indiana, United States, 46260

United States, Iowa
	University of Iowa Hospitals and Clinics
	Iowa City, Iowa, United States, 52242

United States, Missouri
	Washington University
	St. Louis, Missouri, United States, 63110

United States, North Carolina
	Duke University Medical Center
	Durham, North Carolina, United States, 27705

United States, Pennsylvania
	Children's Hospital of Philadelphia
	Philadelphia, Pennsylvania, United States, 19104
	Children's Hospital of Pittsburgh
	Pittsburgh, Pennsylvania, United States, 15213

United States, Tennessee
	U of Tennessee HELP Center
	Memphis, Tennessee, United States, 38103

United States, Texas
	Texas Children's Hospital
	Houston, Texas, United States, 77030
	UT Southwestern Children's Medical Center of Dallas
	Dallas, Texas, United States, 75390

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CSMS995B2403
First Received:	January 21, 2004
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00076362
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Octreotide

Nutrition Disorders

Overweight

Overnutrition

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Gastrointestinal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00076362