Somatuline Autogel: Acromegaly Self/Partner Injection Study

What Was Tested

This registered phase 4 trial tested Lanreotide.

The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home.

Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 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: The patient must have a clinical diagnosis of acromegaly. The patient must be able to store study medication in a refrigerator in their own home.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: the patient has had pituitary surgery (adenomectomy) within 6 months prior to screening; the patient has received pituitary radiotherapy within one year prior to screening; the patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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 2004-02 with completion listed for 2005-08-24.

It ran at 10 sites in United Kingdom (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.

It also tracked 3 secondary outcomes, for example To assess patient/partner and healthcare professional experience with unsupervised injections and To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Lanreotide in 30 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.