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

Hypothalamic Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171613
• Other study ID #: CSMS995B2403E1
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 27, 2012
• Start date: February 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothalamic Obesity
• Obesity

Intervention

Drug:
• Octreotide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in BMI
Secondary	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