Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas

What Was Tested

The trial (phase 2) is built around Lanreotide.

It had two arms (groups): Group 2 (other) and Group 1 (experimental).

After a baseline evaluation, patients underwent transsphenoidal surgery (direct surgery group).

The registry classes the interventions as drug and procedure.

More on the Plan

Clinical features of acromegaly include acral enlargement, prognathism, jaw malocclusion, arthropathy, carpal tunnel syndrome, hyperhydrosis, sleep apnea, and visceromegaly.

Its effects on GH and insulin-like growth factor I (IGF-I) secretion are rapid and operations have a low morbidity and very low mortality.

However, surgery for macroadenomas causing acromegaly has a much lower surgical success rate than that for microadenomas.

Who Took Part

96 planned participants were the target.

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 with newly diagnosed acromegaly due to GH-secreting macro-adenomas. Pituitary macroadenomas (maximum diameter \>1 cm) verified by a pituitary magnetic resonance imaging (MRI) scan. Age between 18 and 80 yr.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: immediate surgery indicated by clinical criteria; contraindications to mri scan; patients judged not suitable to participate in the study for other reasons such as personality disorders and alcohol abuse.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

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

It started in 2004-01 with completion listed for 2009-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Lanreotide in 96 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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