A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.

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Key information

Conditions

Hypothalamic Obesity Body Weight Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Gonadal Dysgenesis Hypogonadism Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sexual Infantilism Signs and Symptoms Urogenital Abnormalities Urogenital Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient must provide written informed consent

Exclusion criteria

Any patient that experienced unresolved safety complications at any time during the original protocol CSMS995B2403
Patients with a history of gallstones or any patient developing gallstones during the course of the core protocol
Patients for whom there are safety or tolerability concerns for continuing Octreotide Depot
Any patient requiring additional treatment for their original cranial insult related to cranial trauma, or to tumor recurrence or its treatment Refer to the original protocol for details of inclusion & exclusion criteria. Any patient granted a waiver to participate in the core protocol will be allowed to continue to participate in the extension protocol.

Other protocol-defined inclusion / exclusion criteria may apply.

Treatment and study plan

Octreotide

Drug

Primary outcomes

Change from baseline in BMI

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start: 2005
Primary completion: 2005
First posted: Sep 15, 2005
Registry last updated: Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed