Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

What Was Tested

This registered phase 3 trial tested Octreotide and Pasireotide.

The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

Following one year of treatment patients could proceed into the study extension.

It had two arms (groups): Pasireotide LAR (experimental) and Octreotide LAR (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 358 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: Patients with active acromegaly (based on elevated GH and IGF-1 levels). Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patients with compression of the optic chiasm causing any visual field defect; patients who have received pituitary irradiation within the last ten years prior to visit 1; poorly controlled diabetic patients.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-02-11 with completion listed for 2016-03-11.

It ran at 95 sites in United States (14), France (7), Italy (7), Brazil (6), Canada (5) and Germany (5).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 25 secondary outcomes, for example Change From Baseline in Tumor Volume at 12 Months, Percentage of Participants With Normalization of IGF-1, Summary of Mean GH Values, Severity Scores of Acromegaly Symptoms, Ring Size and Health-related Quality-of-life as Measured by the AcroQoL Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide and Pasireotide in 358 people.

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

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