CTRI/2019/01/017317已完成3 期
Efficacy and safety of olanzapine as an add on therapy in children receiving highly emetogenic chemotherapy: A Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
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
入选标准
- •1) Planned for single day highly emetogenic chemotherapy (as defined by Pediatric Oncology Group of Ontario guidelines)
- •2) Absolute neutrophil count > 1000/mm3, Platelet count > 1 lakhs
- •3) SGOT/SGPT < 3 times upper limit of normal and serum bilirubin < 1.5 times upper limit of normal
- •4) Written informed consent
排除标准
- •1) Hypersensitivity to olanzapine
- •2) Patients with primary/ metastatic brain tumor
- •3) Received olanzapine within 3 weeks or another antipsychotic 30 days prior to enrolment
- •4) CYP1A2 inducers or inhibitors while receiving olanzapine
- •5) Vomiting within 24 hour prior to treatment
- •6) Steroids within 24 hour prior to enrolment
研究者
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