NCT00169572已完成2 期
See Detailed Description
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 51
- 主要终点
- The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
研究概览
简要总结
This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.
详细描述
Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- •Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
- •Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
排除标准
- •Not received any investigational product within 30 days of enrolment into the study.
- •Must not be pregnant.
- •Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- •Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
- •Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
- •Must not have a history of peptic ulcer disease.
结局指标
主要结局
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
次要结局
- Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.
研究者
研究点 (51)
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