Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00359567|
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : July 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-Induced Nausea and Vomiting||Drug: palonosetron Drug: granisetron hydrochloride||Phase 3|
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 0.75 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 0.75 mg palonosetron group or a single-dose of 40 μg/kg granisetron hydrochloride with covariates of chemotherapy regimen, gender and age. A palonosetron group will receive intravenous injections of 0.75 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 40μg/kg 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||August 2007|
intravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
Active Comparator: 2
Drug: granisetron hydrochloride
intravenous injections of palonosetron placebo and then 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
- Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting
- Safety profile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359567
|National Cancer Center|
|5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045|
|Principal Investigator:||Tomohide Tamura, MD||National Cancer Center|