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临床试验/EUCTR2017-003535-11-NL
EUCTR2017-003535-11-NL进行中(未招募)1 期

The added value of the H2-antagonist ranitidine in premedication regimens during paclitaxel treatment - RANISTOP

Erasmus MC0 个研究点目标入组 554 人开始时间: 2018年6月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Erasmus MC
入组人数
554

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Age =18 years;
  • Able and willing to give written informed consent;
  • Planned treatment with regular paclitaxel based chemotherapy for any indication and with any dose.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 189
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 365

排除标准

  • Prior treatment with a paclitaxel based regimen;
  • Known hypersensitivity to paclitaxel, carboplatin, docetaxel, ranitidine, dexamethasone, clemastine, granisetron, ondansetron or excipients;
  • Unwilling to stop the use of H2-antagonists for gastroduodenal reflux and ulcer disease. The H2-antagonist should be stopped at least two days before the first paclitaxel infusion (washout). Switching an H2-antagonist to a proton pump inhibitor is allowed.

研究者

发起方
Erasmus MC

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