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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171613
First received: September 13, 2005
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Hypothalamic Obesity
Drug: Octreotide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in BMI

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 32
Study Start Date: February 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171613

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171613     History of Changes
Other Study ID Numbers: CSMS995B2403E1
Study First Received: September 13, 2005
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014