ISRCTN84460768已完成不适用
Effect of additional single or repeated dosage of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour: a multicentre open one-arm non-randomised trial
InDex Pharmaceutials AB (Sweden)0 个研究点目标入组 30 人开始时间: 2009年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Adult men and women (greater than 18 year) with malignant brain oedema confirmed by MRI/computed tomography (CT), caused by malignant glioma, menigioma or metastatic disease (histological and/or cytological verified)
- •2. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance 0 - 3
- •3. Betapred® (betamethasone) dose 8 mg x 2 for more than 24 hours
- •4. Clinical need for increase of corticosteroid dosage
- •5. Possibility to perform repeated MRI examinations
排除标准
- •1. History and precence of a clinical significant cardiovascular, hepatic, haematological, endocrine, neurological and psychiatric disease or immune compromised state as judged by the investigator
- •2. Chemotherapy that has been administrated within 4 weeks prior to inclusion
- •3. Positive urine pregnancy test in women at enrolment
- •4. Intake of drug under investigation
研究者
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