NCT00996983进行中（未招募）2 期
Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
National Cancer Institute, Naples1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Response rate (> 30% reduction in VASPI)
研究概览
简要总结
Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.
详细描述
The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of neoplasm
- •Neuropathic pain level VASPI > or = 6 (0-10 scale)
- •Inadequate pain relief with opioid analgesics and adjuvants
- •Age > or = 18 years
- •Performance status ECOG 0-2
- •Life expectancy at least one month
- •Adequate contraception in women of child-bearing potential
- •Signed Informed Consent
排除标准
- •Use of experimental drugs within previous 30 days
- •Pregnancy or lactation
- •Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
- •Presence of cerebral metastasis
- •Contraindication to the use of ziconotide
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
A
Experimental
干预措施: ziconotide (Drug)
结局指标
主要结局
Response rate (> 30% reduction in VASPI)
时间窗: 48 hours after completion of titration phase
次要结局
- toxicity(daily during drug titration, weekly thereafter)
- duration of analgesic response(weekly)
研究者
研究点 (1)
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