Track topics on Twitter Track topics that are important to you
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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Chemotherapy-Induced Nausea and Vomiting
palonosetron, granisetron hydrochloride
National Cancer Center
5-1-1 Tsukiji, Chuo-ku, Tokyo
Taiho Pharmaceutical Co., Ltd.
Published on BioPortfolio: 2014-08-27T03:43:14-0400
RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: Randomized phase III trial to compare the effective...
This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydroc...
NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-ne...
Primary Objectives: - Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy. - To determi...
RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with radiation therapy. It is not yet known whether lerisetron is more effective than gran...
Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study.
The preemptive multimodal pain protocols used in total knee arthroplasty (TKA) often cause emesis postoperatively. We investigated whether palonosetron prophylaxis reduces postoperative nausea and vom...
health practitioners, especially oncology nurses, play an important role in assessing and managing chemotherapy-induced nausea and vomiting (CINV). Oncology nurses need adequate knowledge and skills t...
Prevention of nausea and vomiting is of paramount importance for ensuring that patients undergoing anticancer treatments have optimal quality of life. The oral fixed-dose combination of netupitant/pal...
Radiotherapy-induced nausea and vomiting is a common side effect of radiotherapy. It is well-established that nausea and vomiting have a negative impact on quality of life, but the relative influence ...
NEPA is the first fixed-combination antiemetic composed of the neurokinin-1 receptor antagonist netupitant (netupitant; 300 mg) and the 5-hydroxytryptamine-3 receptor antagonist palonosetron (palonose...
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
A serotonin receptor (5HT-3 selective) antagonist that has been used as an antiemetic for cancer chemotherapy patients.
A dopamine antagonist that is particularly useful in treating the nausea and vomiting associated with anesthesia, mildly emetic cancer chemotherapy agents, radiation therapy, and toxins. This piperazine phenothiazine does not prevent vertigo or motion sickness. (From AMA Drug Evaluations Annual, 1994, p457)
A drug combination that contains DIPHENHYDRAMINE and THEOPHYLLINE. It is used for treating vertigo, motion sickness, and nausea associated with pregnancy. It is not effective in the treatment of nausea associated with cancer chemotherapy.
FEVER accompanied by a significant reduction in NEUTROPHIL count associated with CHEMOTHERAPY.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...