JPRN-UMIN000014214已完成2 期
A double-blind randomized phase II study of olanzapine 10mg versus 5mg for highly emetogenic chemotherapy-induced nausea and vomiting. - Trial of olanzapine 10mg versus 5mg for emesis induced by HEC.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
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 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. history of hypersensitivity or allergy for study drugs or similar compounds. 2. patients who do not have enough general condition to the antineoplastic agents treatment. 3. symptomatic brain metastasis. 4. patients who has a convulsive disorders that need anticonvulsants therapy. 5. patients with a symptom who has ascites or pleural effusion that need puncture. 6. patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc. 7. pregnant, breastfeeding or expecting woman. 8. patients enforced radiotherapy in the abdominal or pelvic field between 6 days before and 6 days after chemotherapy. 9. patients who take a medicine, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc within 48 hours prior to beginning chemotherapy. 10. patients who take opioids within 48 hours prior to beginning chemotherapy. 11. patient who is taking pimozide, clarithromycin, ketoconazole, itraconazole, barbiturate (primidone, phenobarbital), rifampicin, phenytoin, carbamazepine, fluvoxamine maleate, ciprofloxacin. 12. patients who take a medicine regularly, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine, agents, etc. 13. patients who take adrenaline within 48 hours prior to beginning chemotherapy. 14. patients who had diabetes mellitus or past history of diabetes mellitus or HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. 15. patients who cannot be hospitalized during 6 days (0-120 h). 16. judged by the investigator to be inappropriate for this study.
研究者
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