Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel

What Was Tested

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

The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.

It had 1 arm (groups): Somatuline Autogel (lanreotide acetate) (experimental).

Somatuline Autogel (lanreotide acetate) Injection.

The registry classes the interventions as behavioral and drug.

More on the Plan

Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection.

Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not a viable option.

Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe, thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection.

Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic.

Who Took Part

The registry lists 59 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 subject must give signed informed consent before any study-related activities. The partner, if applicable, must give signed informed consent before administration of Somatuline Autogel. The subject must be able to understand the protocol requirements. The subject must have a clinical diagnosis of acromegaly due to pituitary tumor. Switch subjects must have had their last pre-study routine clinical treatment with Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment).

The full record lists 12 inclusion and 13 exclusion criteria; among the exclusions: the subject has had pituitary surgery (adenomectomy) within 3 months prior to screening; the subject has received pituitary radiotherapy within 3 years prior to screening; the subject has received a gh receptor antagonist within 6 months prior to screening.

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 2007-04 with completion listed for 2008-12.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score (time frame: 24 weeks).

It also tracked 6 secondary outcomes, for example Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study, Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination, Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients, Total Symptom Questionnaire Score at Week 24/Termination and Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Lanreotide in 59 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.