NCT00666783已完成2 期
A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2008年4月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
研究概览
简要总结
This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
- •naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
- •Karnofsky index more than 70% and anticipated survival time more than 90 days
- •Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
- •No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
- •Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function )
- •Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
- •Provision of written informed consent
排除标准
- •Inability to understand or cooperate with study procedures
- •Receipt of investigational drugs 30 days before study entry
- •Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
- •Contraindications to 5-HT3 receptor antagonists
- •Woman Patient with Pregnancy or lactation
- •Diagnosed with hypertension or severe infectious diseases
- •Obstructive symptom of gastrointestinal tract
- •Symptomatic brain metastasis or mental dysfunction
- •Baseline QTc > 500 ms
研究组 & 干预措施
PAL
Experimental
receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)
干预措施: palonosetron (Drug)
GRA
Active Comparator
receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)
干预措施: Granisetron (Drug)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric PatientsPostoperative Nausea and VomitingNCT01395901Helsinn Healthcare SA670
已完成
3 期
Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and VomitingLaparoscopic Gynecologic, Abdominal, Other SurgeryGeneral AnesthesiaNCT01568268Samsung Medical Center384
已完成
3 期
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric PatientsPostoperative Nausea and VomitingNCT00828295Helsinn Healthcare SA150
已完成
4 期
Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)NeoplasmsNauseaVomitingNCT00687011Merck Sharp & Dohme LLC118
已完成
3 期
Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric PatientsChemotherapy-Induced Nausea and VomitingNCT01442376Helsinn Healthcare SA502