Lanreotide Autogel-[amount hidden] as First-Line Treatment of Acromegaly

What Was Tested

The trial (phase 4) is built around Lanreotide.

The ATG formulation consists of a solution of lanreotide in water with no additional excipients.

It had 1 arm (groups): A (experimental).

Newly diagnosed patients with acromegaly.

The registry classes the interventions as drug.

More on the Plan

The study population will consist of at least 20 patients, enrolled in the two centers from Jan 1st 2003 to June 30th 2007.

Patients give their written informed consent prior to entering into the study.

Hormonal evaluation GH levels are assessed as a mean value of 5 samples at 30-min intervals (starting between 08:00 and 9:00 in the morning) taken at each visit before the injection of ATG.

IGF-I levels are assessed as a single sample taken at each visit at the same time as the first GH sample.

Who Took Part

Enrollment: 27 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients never treated before. Patients who do not require immediate surgery because of neurological symptoms and/or emergency conditions. Patients who signed an informed consent to participate to the study.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: patients already treated before with surgery or radiotherapy or with medical treatment; patients with mixed gh-prl adenomas who require combined somatostatin and dopamine treatment.

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 2003-01 with completion listed for 2007-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Control of GH and IGF-I excess and tumor shrinkage (time frame: 3 and 12 months).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Lanreotide in 27 people.

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

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

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