Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226655
Status:
COMPLETED
Last Update Posted:
2012-08-31
First Post:
2005-09-23
Brief Title:
An Open-Labeled Extended-Use of XERECEPT hCRF for Patients in Studies NTI 0302 0303 or Other Designated Studies
Sponsor:
Celtic Pharma Development Services
Organization:
Celtic Pharma Development Services
Study Overview
Official Title:
An Open-Labeled Extended-Use of Human Corticotropin-Releasing Factor hCRF Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302 NTI 0303 or Other Designated Studies
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor hCRF XERECEPT in patients requiring dexamethasone Decadron to treat peritumoral brain edema This open-label extended-use study is open to all patients who participate in either of the blinded studies NTI 0302 NTI 0303 or other designated studies including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods
Detailed Description:
XERECEPT is not a potential treatment for cancer but may reduce the edema associated with tumors and as a result decrease neurological symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None