EUCTR2010-020087-38-GB进行中（未招募）不适用
Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patient Global Perceived Effect in Intrathecal Therapy for Pain. - Bolus versus Continuous Study
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
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
- •Participants who :
- •1. Are implanted with a programmable Intrathecal Therapy Drug Device (ITDD)
- •2. Have achieved stable pain relief on continuous flow.
- •3. Are capable of giving informed consent.
- •4. Are willing to sign the Informed Consent form
- •5. Are male or female and aged between 18yrs and 65yrs of age
- •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
- •Participants who:
- •1. Fail to give informed consent
- •2. Are incapable of answering the questionnaires; PGIC,EQ-5D, VAS Score for physical or psychological reasons
- •3. Have non-Programmable Device ITDD
- •4. Have Patient Therapy Manager devices (PTM's)
- •5. Are using Ziconotide Intrathecal Therapy
- •6. Are programmed with bolus doses (flex doses)
- •7. Have severe limitation in function and mobility
- •8. Are pregnant or lactating
- •9. Are not practicing a safe method of birth control
研究者
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