Efficacy and Safety of Lanreotide Autogel ([amount hidden]) in Acromegalic Patients

What Was Tested

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 63 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: Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patient having had pituitary surgery within the previous 3 months; patient having received radiotherapy for acromegaly disease within the previous 36 months; patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period.

How the Study Was Run

The set-up was non-randomized, 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 2000-09 with completion listed for 2002-07-15.

It ran at 17 sites in France (16) and Switzerland (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48).

It also tracked 6 secondary outcomes, for example Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range, Mean growth hormone (GH) levels, Number of patients having a serum GH level at or below 2.5ng/ml and Number of patients having a serum GH level at or below 1 ng/ml.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Lanreotide in 63 people.

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.