Status:
COMPLETED
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
Lead Sponsor:
Novartis
Conditions:
Hypothalamic Obesity
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief 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 ra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00171613
Start Date
February 1 2005
Last Update
April 30 2012
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