Conditions: Cushing's Disease
Keywords: SOM230 Cushing's Disease Mean Urinary Free Cortisol Pasireotide Pasireotide LAR Pasireotide long-acting release secondary hypercortisolism secondary hypercorticism Itsenko-Cushing disease increased secretion of adrenocorticotropic hormone (ACTH) hyperpituitarism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Detailed description:

Arms:
arm 1: Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. arm 2: Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.

Interventions: intervention 1: pasireotide LAR intervention 2: SOM230 LAR 30 mg intervention 3: SOM230 LAR 10 mg
Intervention descriptions: intervention 1: Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons). intervention 2: starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose. intervention 3: starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.

Protocol document: