NCT00684463已完成4 期
Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older.
- •Histological or cytological confirmation of malignant disease.
- •Karnofsky index >= 50%
- •Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
- •Patients that voluntarily sign the consent form.
排除标准
- •Pregnancy or suspected.
- •Patients during breast feeding.
- •Inability to understand or cooperate with the study procedures.
- •Received any investigational drugs within 30 days before study entry.
- •Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
- •Seizure disorders requiring anticonvulsant medication.
- •Persistent vomiting due to any organic etiology.
- •Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
- •Any systemic disease different to base disease
- •Known current or history of drug or alcohol abuse
- •Gastric outlet or intestinal obstruction
研究组 & 干预措施
Palonosetron
Experimental
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent
干预措施: Palonosetron (Drug)
结局指标
主要结局
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
时间窗: During 24 hours after administration of chemotherapy.
次要结局
- Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication(Days 1 to 5 at different time intervals for each secondary outcome.)
- Number of emetic episodes(Days 1 to 5 at different time intervals for each secondary outcome.)
- Proportion of patients who achieved a CR and of those who achieved complete control(Days 1 to 5 at different time intervals for each secondary outcome.)
研究者
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