Clinical trial

Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)

Name
CSOM230B2410
Description
This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.
Trial arms
Trial start
2013-03-28
Estimated PCD
2023-07-10
Trial end
2023-07-10
Status
Completed
Treatment
SOM230
Arms:
Pasireotide
Size
151
Primary endpoint
Number of Participants with Adverse Events as a Measure of Safety and Tolerability profile of pasireotide s.c.
3-year follow-up
Eligibility criteria
Inclusion Criteria: * Male or female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option * Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry Exclusion Criteria: * Patients with ectopic ACTH-dependent Cushing's syndrome * Patients with adrenal Cushing's syndrome * Patients with Pseudo Cushing's syndrome
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 151, 'type': 'ACTUAL'}}
Updated at
2024-04-17

1 organization

1 product

1 indication

Organization
Recordati Group
Product
SOM230