This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

Ages Eligible for Study:   6 Years to 17 Years   (Child)
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
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 identifier: NCT00171613

Sponsors and Collaborators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis Identifier: NCT00171613     History of Changes
Other Study ID Numbers: CSMS995B2403E1
Study First Received: September 13, 2005
Last Updated: April 27, 2012

Keywords provided by Novartis:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on August 18, 2017