An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly

What Was Tested

In this phase 2 trial, researchers set out to test Pasireotide.

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma.

It had 1 arm (groups): Pasireotide s.c. Overall (experimental).

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 up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study csom230b2201; participants who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study csom230b2201.

How the Study Was Run

The set-up was single-group and open-label.

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 2004-08-24 with completion listed for 2013-12-06.

It ran at 10 sites in United States (3), Germany (2), Australia (1), Belgium (1), France (1) and Italy (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Time to Tumor Response, Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes, Percentage of Participants With Symptoms of Acromegaly, Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation and Percentage of Participants With One or More Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Pasireotide in 30 people.

Its size is small, so on its own it can only give an early look.

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.