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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 15, 2014