A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

What Was Tested

This registered phase 4 trial tested Lanreotide.

If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed.

This study has two phases.

It had 1 arm (groups): Somatuline Depot Subcutaneous (SC) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 4 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18 - 75. Visible pituitary adenoma (microadenoma or macroadenoma) on high quality pituitary MRI without and with gadolinium. Prior treatments for acromegaly with surgery, somatostatin analogs or pegvisomant are acceptable if these therapies have been discontinued for at least 3 months prior to study entry.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: age \< 18 or \> 75 years; acromegalic patients currently on a lanreotide or octreotide preparation or on pegvisomant; patients who have received prior radiotherapy or radiosurgery.

How the Study Was Run

The set-up was single-group and open-label.

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

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

It started in 2013-05 with completion listed for 2016-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Early Remission of Acromegaly (time frame: 3 months post-op).

It also tracked 4 secondary outcomes, for example Change in Cardiac Function, Change in Hypertension, Change in Respiratory Function and Change in Quality of Life.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Lanreotide in 4 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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