Clincosm LogoSign in Get a demo

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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00171613
Collaborator
(none)
32
Enrollment

Study Details

Study Description

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 randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
Study Start Date :
Feb 1, 2005
Actual Primary Completion Date :
Oct 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in BMI []

Secondary Outcome Measures

  1. 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

No locations specified.

Sponsors and Collaborators

  • Novartis

Investigators

  • Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00171613
Other Study ID Numbers:
  • CSMS995B2403E1
First Posted:
Sep 15, 2005
Last Update Posted:
Apr 30, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Novartis
Obesity
Additional relevant MeSH terms:
Obesity
Octreotide

Study Results

No Results Posted as of Apr 30, 2012