JPRN-UMIN000012502已完成未知
Protective efficacy of the prochlorperazine for oxycodone-induced nausea and vomiting for patients with cancer pain Randomized placebo control double-blind trial (phase III study) - POINT study
agoya University Hospital Department of Clinical Oncology and Chemotherapy0 个研究点目标入组 120 人开始时间: 2013年12月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 100years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)PS (performance status) 4 patients) of ECOG(Eastern Cooperative Oncology Group) (2)The patients whom condition is unstable in for digestive system disease (including reflux oesophagitis, a gastric ulcer, gastrointestinal obstruction, constipation) (3)There is the electrolyte abnormality with "nausea (CTC-AE Grade2 )" or "the vomiting-related event" the patients (4)With "nausea (CTC-AE Grade2 )" or "the vomiting-related event" by other causes the patients (5)The patients with a symptomatic central nerve lesion (including brain metastasis, cancer-related meningitis) (6)We correct the patients who they received head, abdomen (it is assumed that it is lower than diaphragm) or pelvic radiotherapy during - study period six days ago or are going to receive it with study drug initiation, and, as for the localized radiotherapy, combination is possible on the bone part with bone metastases (7)Within 48 hours before study drug initiation, it is the patients using the drug (including a digitalis, the chalybeate) with the emetic action. However, it is excluded when we use it regularly for more than study drug initiation one week (8)Within 48 hours before study drug initiation, it is the patients using the drug with the antiemetic activity. (9)It is the patients who used a medical drug in treatment regularly with cancer pain within three months before registration. (10)It is the patients with a history of hypersensitivity to a prochlorperazine (11)Patients to be contraindicated to prochlorperazine (12)It is the patients with a history of QTc prolongation (QTc> 470msec) with a past electrocardiogram. However, when there is no QTc prolongation in the electrocardiogram within three months before registration, registration is possible (13)The patients with other serious complications (14)Within one week before study drug initiation, it is the patients using an anticancer drug or the molecular target medicine with non-administration in the past
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