NCT00273468已完成3 期
A Randomised, Active Control, Double-blind, Double-dummy, Parallel-group, Multi-national Study to Assess the Efficacy, Tolerability and Safety of the Granisetron Transdermal Delivery System in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Moderately or Highly Emetogenic Multi-day Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 630
- 主要终点
- Percentage of patients achieving Complete Control of CINV from the first administration until 24 h after the last administration of the moderately or highly emetogenic chemotherapy
研究概览
简要总结
To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be of non-childbearing potential and female patients must have a negative pregnancy test at the Screening Visit
- •Histologically and/or cytologically confirmed cancer with ECOG ≤2
- •Life expectancy of ≥ 3 months
- •Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days
排除标准
- •Hypersensitivity to adhesive plasters
- •Contraindications to 5-HT3 receptor antagonists
- •Clinically relevant abnormal laboratory values or hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator
- •Any cause for nausea and vomiting other than CINV
- •Clinically relevant abnormal ECG parameters
- •Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
- •A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder
结局指标
主要结局
Percentage of patients achieving Complete Control of CINV from the first administration until 24 h after the last administration of the moderately or highly emetogenic chemotherapy
次要结局
- Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)
- Time from start of chemotherapy to first administration of rescue medication
- Adverse events collected until 14 days after patch removal
- Time from start of chemotherapy to first emetic episode (vomiting/retching)
- Percentage of patients achieving CC and CR of CINV during different time periods
- Patch adhesion
研究者
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