Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 11:03 AM
Study NCT ID:
NCT00982995
Status:
TERMINATED
Last Update Posted:
2015-12-04
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
Study Overview
Official Title:
UMCC 2008.048 Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
site terminated due to lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HUM21469
Brief Summary:
The primary objective of this study is to determine the complete response (no vomiting and no need for other medications to treat nausea) in terminally ill patients suffering from nausea and/or vomiting, who are treated with palonosetron. Another objective is to determine the partial response (relief of nausea and vomiting to the extent that the patient wishes to continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy. The investigators are testing this medication to see if it can help to relieve nausea and vomiting not associated with chemotherapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: