NCT01148264终止2 期
Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide
Karin Jordan1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Clinical benefit rate
研究概览
简要总结
This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.
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 (Participant, Investigator)
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
- •break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS
- •signed IC
排除标准
- •psychiatric disorders
- •drug abuse
- •pregnancy
- •high dose chemotherapy
- •treatment with other antiemetic drugs
研究组 & 干预措施
olanzapine
Experimental
干预措施: olanzapine (Drug)
metoclopramide
Active Comparator
干预措施: metoclopramide (Drug)
结局指标
主要结局
Clinical benefit rate
时间窗: three days
no vomitus, no further rescue medication, nausea \< 25mm on the visual analog scale (VAS) or reduction on the VAS of \>50%
次要结局
- change in urinary excretion of 5 hydroxy indole acetic acid(5 days)
- Quality of life(5 days)
- safety(five days)
研究者
Karin Jordan
MD
Martin-Luther-Universität Halle-Wittenberg
研究点 (1)
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