Prader-Willi Syndrome and Appetite

Plain-language guide to NCT00175305: phase 3 randomized trial of Octreotide, hyperparathyroidism, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00175305
Phase: phase 3
Status: terminated early
Start: 2004-08
Completion (planned or actual): 2007-10
Participants: 10 (estimated)
Design: randomized, double-blind, treatment
Conditions studied: Hyperphagia; Prader-Willi Syndrome
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Octreotide for hyperparathyroidism.

Ghrelin is a powerful appetite-stimulating hormone.

The registry classes the interventions as drug.

More on the Plan

Prader-Willi Syndrome and Obesity: Prader-Willi syndrome (PWS) is a genetic disorder occurring in 1/10,000 to 1/15,000 live births.

Clinical characteristics include neonatal and infantile central hypotonia with feeding problems and poor weight gain followed after 1-3 years by hyperphagia and excessive weight gain.

Obesity is clearly one of the cardinal features of PWS.

Recently, studies on the effects of growth hormone (GH) treatment (now an approved indication in most patients with PWS in the US irrespective of their GH status) on body composition in PWS have been performed.

Who Took Part

The registry lists 10 planned participants were the target.

It was open to people of any sex aged from 10 years up to 17 years.

Examples of who could join: Patients with Prader-Willi syndrome, confirmed by genetic testing.

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The hyperparathyroidism participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the hyperparathyroidism participants stayed in one arm throughout.

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

It started in 2004-08 with completion listed for 2007-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in ghrelin concentrations during a test meal (time frame: 8 to 10 AM).

It also tracked 1 secondary outcome, for example Change in weight, behaviour and food intake.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 10 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Hyperparathyroidism research.

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.