Pediatric Hypothalamic Obesity

What Was Tested

In this phase 4 trial, researchers set out to test Octreotide.

This trial is being conducted in pediatric patients with Hypothalamic Obesity.

This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones).

The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age.

The registry classes the interventions as drug.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female patients ages 6 to less than 18. Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it's treatment (i.e. surgery, radiation, and/or chemotherapy). Patients who are at least one year out following therapy for their tumor. Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded. Patients with severe neurologic handicaps which preclude normal physical activity will be excluded.

The full record lists 7 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, single-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2004-03 with completion listed for 2005-07.

It ran at 15 sites in United States (15).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in BMI.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.