- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171613
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
April 27, 2012 updated by: Novartis
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.
Study Overview
Study Type
Interventional
Enrollment
32
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline in BMI
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (ACTUAL)
October 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
April 30, 2012
Last Update Submitted That Met QC Criteria
April 27, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSMS995B2403E1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypothalamic Obesity
-
Rhythm Pharmaceuticals, Inc.Recruiting
-
LG ChemNot yet recruiting
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Rhythm Pharmaceuticals, Inc.Completed
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Rhythm Pharmaceuticals, Inc.Enrolling by invitationHypothalamic ObesityUnited States, Canada, United Kingdom, Germany, Netherlands
-
SanionaWithdrawnHypothalamic ObesityUnited States
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Children's Hospitals and Clinics of MinnesotaAmylin Pharmaceuticals, LLC.Completed
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Seattle Children's HospitalChildren's Hospital of PhiladelphiaNot yet recruitingCraniopharyngioma | Hypothalamic Obesity | Hypothalamic TumorUnited States
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SanionaCompletedHypothalamic Injury-induced Obesity (HIO)Denmark
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Seattle Children's HospitalVanderbilt University; Children's Hospitals and Clinics of MinnesotaCompletedHypothalamic ObesityUnited States
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Debra Weese-MayerROHHAD Fight Inc.RecruitingROHHAD | Rapid-Onset Obesity With Hypothalamic Dysfunction, Hypoventilation & Autonomic DysregulationUnited States
Clinical Trials on Octreotide
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AdventHealthTerminatedAdenomaUnited States
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Aspireo Pharmaceuticals LimitedCompleted
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Mayo ClinicCompletedCirrhosis | Portal Hypertension | Esophageal Varices
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Chengfeng WangUnknown
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Novartis PharmaceuticalsCompletedChemotherapy-induced DiarrheaBrazil
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Qilu Pharmaceutical Co., Ltd.CompletedHealthy VolunteersChina
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Peking UniversityUnknownEsophageal Neuroendocrine Carcinoma | Gastro-entero-pancreatic CarcinomaChina
-
Qilu Hospital of Shandong UniversityNot yet recruitingNeuroendocrine TumorsChina
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Azidus BrasilSuspended
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Cliniques universitaires Saint-Luc- Université...TerminatedNeuroendocrine Tumors | Carcinoid Syndrome