Pediatric Hypothalamic Obesity
Tracking Information | |||||
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First Received Date ICMJE | January 21, 2004 | ||||
Last Updated Date | September 8, 2011 | ||||
Start Date ICMJE | March 2004 | ||||
Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change from baseline in BMI | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00076362 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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 | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Pediatric Hypothalamic Obesity | ||||
Official Title ICMJE | |||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Obesity | ||||
Intervention ICMJE | Drug: Sandostatin LAR | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 60 | ||||
Completion Date | |||||
Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
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Gender | Both | ||||
Ages | 6 Years to 18 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00076362 | ||||
Other Study ID Numbers ICMJE | CSMS995B2403 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novartis | ||||
Verification Date | September 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |