Ultrasound Guided Octreotide LAR Injection in Acromegaly

What Was Tested

The trial (phase 4) is built around Octreotide.

Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR.

This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment.

It had two arms (groups): Ultrasound-guided IM injections of octreotide LAR (experimental) and Regular IM injections of octreotide LAR (active comparator).

The registry classes the interventions as drug.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diagnosis of active acromegaly based on evidence of a pituitary tumor. Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) \< 1 ng/mL during an oral glucose tolerance test.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: uncontrolled diabetes mellitus; pregnant or breast feeding; current gallstones.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Octreotide and the comparison at some point, usually with a gap in between.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-07 with completion listed for 2014-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Plasma Octreotide Level After Each Treatment Phase (time frame: 3 months).

It also tracked 1 secondary outcome, for example Serum IGF-1 Level.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 15 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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