Pediatric Hypothalamic Obesity
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00076362
First received: January 21, 2004
Last updated: September 8, 2011
Last verified: September 2011
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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 4 |
| 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:
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 | 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 May 16, 2013