Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

What Was Tested

The trial (phase 3) is built around Pasireotide.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 162 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: 18 years or greater. Confirmed diagnosis of ACTH-dependent Cushing's disease. Not considered candidate for pituitary surgery.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: history of pituitary irradiation in the last 10 years; cushing's syndrome not caused by pituitary tumor; patients with active malignant disease (cancer) in the last 5 years.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Pasireotide group and the comparison group ran side by side rather than switching.

As a double-blind Pasireotide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2006-12 with completion listed for 2010-03.

It ran at 68 sites in United States (10), France (9), Italy (9), Brazil (6), Germany (4) and Israel (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 14 secondary outcomes, for example Change From Baseline in mUFC, Time to First UFC Response, Percent Change From Baseline in Serum Cortisol, Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH), Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI) and Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Pasireotide in 162 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.