Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498037
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-26
Brief Title:
Optimizing Subcutaneous FEntanyl titRation RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Optimizing Subcutaneous FEntanyl titRation RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FERRARI
Brief Summary:
The primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with SC fentanyl in patients with cancer The primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient
Patients will be treated with additional loading boluses and plasma-PK samples will be obtained
Patients will be treated with additional loading boluses and plasma-PK samples will be obtained
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None