EUCTR2008-005307-26-IT进行中(未招募)1 期
Intratecal Ziconotide in the treatment of neuropatic pain in cancer patients.A phase II study. - ZIDO
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点目标入组 16 人开始时间: 2009年6月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 16
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
- 性别
- All
入选标准
- •1.Diagnosis of malignant tumors; 2. Severe neuropatic pain (VASPI 6 or greater); 3.Pain not responsive to opioids and adjuvant drugs; 4. Age 18 or greater; 5.Performance Status 0-2; Life expectancy greater than 1 month; effective contraception in female patients if the risk of conception exists; 8. Written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Exposure to experimental drugs in the previous 30 days; 2.Nursing and/or pregnant women; 3. Contraindication of intratecal analgesia (including active infections or disorders in liquor circulation); 4.Brain metastases; 5.INR greater than 2; 6.Contraindication of ziconotide use; 7.Incapacity or refusal to sign the informed consent
研究者
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