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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171613
First Posted: September 15, 2005
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171613


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171613     History of Changes
Other Study ID Numbers: CSMS995B2403E1
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Novartis:
Obesity

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