EUCTR2009-012928-89-GB进行中（未招募）不适用
Intrathecal injection of a single dose of Ziconotide (Prialt®) to evaluate the option of continuous administration via implanted pump. A Pilot Study - Ziconotide Bolus injections Study
South Tees NHS Trust0 个研究点开始时间: 2010年10月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Non-bedridden (ambulatory) patient. 2. Age range from 18-65 years of age 3. Patient suffering from chronic pains resistant to the usual treatments and for whom intrathecal administration of analgesics is envisaged 4. Failure of conventional medical management. 5. Patient capable of judgment, who is informed and able to understand the information regarding the drug and the mode of administration 6. Signed 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Refusal to participate in the study; 2. Incapable of using or understanding how to handle the equipment; VAS score 3. Systemic infection, deep or superficial infection of the lumbar area 4. Limited life expectancy and inability to attend 3 times on the surgical day unit 5. Contraindication for implantation of a pump for intrathecal drug administration 6. Allergy to ziconotide or any of the excipients in the ziconotide vial 7. Previous history of psychological disorders which in the investigators opinion would put the patient at risk
研究者
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