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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Octreotide

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.