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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypothalamic Obesity

Treatments: Drug: Octreotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171613

CSMS995B2403E1

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)