Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

What Was Tested

In this phase 3 trial, researchers set out to test Lanreotide.

Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.

The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.

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

The registry classes the interventions as drug.

Who Took Part

108 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: The patient has given written informed consent prior to any study related procedures. The patient is male or female and is aged between 18 and 75 years, inclusive,. The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading,. Not related to the pituitary adenoma. Clinically stable condition not presumed to change during the study period.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: the patient has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure,; the patient is pregnant or lactating,; the patient has a history of, or known current, problems with alcohol abuse,.

How the Study Was Run

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

Being open-label, the Lanreotide study did not mask who received what.

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

It started in 2008-05 with completion listed for 2012-02.

It ran at 27 sites in France (9), Germany (5), Italy (3), United Kingdom (3), Finland (2) and Netherlands (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels, Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels, Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels and Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Lanreotide in 108 people.

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

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