A Study of Octreotide Depot Vs Saline Control in Pediatric Hypothalamic Obesity Patients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171613

Purpose

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.

Condition	Intervention	Phase
Hypothalamic Obesity	Drug: Octreotide	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, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study of Octreotide Depot Vs Saline Control in Pediatric Hypothalamic Obesity Patients

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:	32
Study Start Date:	February 2005

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171613

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSMS995B2403E1
Study First Received:	September 13, 2005
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00171613
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Obesity

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 January 16, 2009