Pediatric Hypothalamic Obesity - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00076362

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

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

Enrollment:	60
Study Start Date:	March 2004
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00076362 History of Changes
Other Study ID Numbers:	CSMS995B2403
Study First Received:	January 21, 2004
Last Updated:	September 8, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012