Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359567
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2006-08-01
Brief Title:
Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy
Sponsor:
Taiho Pharmaceutical Co Ltd
Organization:
Taiho Pharmaceutical Co Ltd
Study Overview
Official Title:
Comparative Study of Intravenous Single Doses of Palonosetron PALO With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy
Status:
COMPLETED
Status Verified Date:
2011-07
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:
To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders such as nausea and vomiting induced by highly emetogenic chemotherapy
Detailed Description:
This study involves prophylactic single dose of granisetron hydrochloride as a control in the treatment of chemotherapy induced nausea and vomiting CINV The primary objective of the study is to verify 075 mg palonosetron concomitantly administered with corticosteroids is not inferior and superior to granisetron hydrochloride in acute stages 0 - 24 hours and in delayed stages 24 - 120 hours after administration of highly emetogenic chemotherapy respectively Corticosteroids are commonly employed in current medical treatments with 5-HT3 receptor antagonists
This is a multicenter parallel group comparative study where subjects are assigned to treatment groups in accordance with a central registration system After obtaining written informed consent the patients that satisfy the inclusion criteria without meeting the exclusion criteria are assigned using minimizing procedures to either a single-dose of 075 mg palonosetron group or a single-dose of 40 μgkg granisetron hydrochloride with covariates of chemotherapy regimen gender and age A palonosetron group will receive intravenous injections of 075 mg palonosetron 5 mL and then granisetron placebo before administration of highly emetogenic chemotherapy A granisetron hydrochloride group will be treated with palonosetron placebo and then intravenous 40μgkg granisetron hydrochloride before administration of highly emetogenic chemotherapy The onset of nausea and emetic episodes and the time of an antiemetic procedure will be observed for 120 hours after the start of highly emetogenic chemotherapy The objective is to find the patients global satisfaction with the antiemetic therapy Adverse events will also be observed for seven days after the administration of the each drug
This is a multicenter parallel group comparative study where subjects are assigned to treatment groups in accordance with a central registration system After obtaining written informed consent the patients that satisfy the inclusion criteria without meeting the exclusion criteria are assigned using minimizing procedures to either a single-dose of 075 mg palonosetron group or a single-dose of 40 μgkg granisetron hydrochloride with covariates of chemotherapy regimen gender and age A palonosetron group will receive intravenous injections of 075 mg palonosetron 5 mL and then granisetron placebo before administration of highly emetogenic chemotherapy A granisetron hydrochloride group will be treated with palonosetron placebo and then intravenous 40μgkg granisetron hydrochloride before administration of highly emetogenic chemotherapy The onset of nausea and emetic episodes and the time of an antiemetic procedure will be observed for 120 hours after the start of highly emetogenic chemotherapy The objective is to find the patients global satisfaction with the antiemetic therapy Adverse events will also be observed for seven days after the administration of the each drug
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