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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ghrelin Suppression by Octreotide in Prader-Willi

NCT01613495

Prader Willis Syndrome

UNKNOWN NA

Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)

NCT00399893

Prader-Willi Syndrome

TERMINATED NA

Effects of Exenatide on Hypothalamic Obesity

NCT01061775

Hypothalamic Obesity

COMPLETED PHASE1/PHASE2

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

NCT06760546

Hypothalamic Obesity Multiple Pituitary Hormone Deficiency Genetic Form Septo-Optic Dysplasia +3 more

RECRUITING PHASE3

Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents

NCT02020395

Endocrine System Diseases

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypothalamic Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Octreotide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No