Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

What Was Tested

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

It had 1 arm (groups): Pasireotide LAR (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients will be categorized into two groups.

After 3 months of treatment have been completed, and prior to the fourth injection a mean GH and IGF-1 will be assessed.

Patients who are achieving biochemical control will be considered a screen failure and they will not qualify for the core phase of the study.

Patients should have been treated with the first generation SSAs for at least 3 months prior to screening.

Who Took Part

123 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: Written informed consent. Male and female patients ≥18 years.

The full record lists 4 inclusion and 28 exclusion criteria; among the exclusions: patients with compression of the optic chiasm requiring surgical intervention; patients who are hypothyroid and not on adequate replacement therapy; patients with symptomatic cholelithiasis and acute or chronic pancreatitis.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.

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

It started in 2015-03-31 with completion listed for 2018-01-08.

It ran at 50 sites in Italy (9), France (8), Turkey (Türkiye) (5), Argentina (3), Belgium (3) and China (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Core Phase: Percentage of Participants With Mean GH < [amount hidden]/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall. Core Phase: Percentage of Participants With Mean GH < [amount hidden]/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR [amount hidden]. Core Phase: Percentage of Participants With Mean GH < [amount hidden]/L and IGF-1 < ULN at Week 36.

It also tracked 18 secondary outcomes, for example Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36, Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36, Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening, Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL), Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms and Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Pasireotide in 123 people.

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

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