NCT03255330撤回3 期
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assessment the analgesic effect of gabapentin
研究概览
简要总结
Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 18 - 65 years
- •Signed written informed consent
- •Patients after complete/non-complete spinal lesion, after surgery
- •Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal)
- •Patient willing and able to comply with the study protocol
- •Male and females with a highly effective method of birth control plus an additional barrier method
排除标准
- •Patients with spinal cord lesion ischemic etiology
- •Pregnant women, nursing or childbearing age with a positive pregnancy test input
- •Patients unable or unwilling to comply with the study protocol
- •Acute pancreatitis in 1 year from the start of the study
- •Chronic pancreatitis in the case history
- •Active or uncontrolled infectious diseases
- •Hypersensitivity to any component of the investigational product
- •Active autoimmune disease
- •Serious neurological disease with the incidence chronic neuropathic pain
研究组 & 干预措施
Arm G1800
Experimental
administration of gabapentin with a gradual increasing dose of up to 1800 mg / day
干预措施: Gabapentin (Drug)
G0
Active Comparator
Standardized medical treatment of central neuropathic pain: metamizole, tramadol
干预措施: Metamizol (Drug)
G0
Active Comparator
Standardized medical treatment of central neuropathic pain: metamizole, tramadol
干预措施: Tramadol (Drug)
结局指标
主要结局
Assessment the analgesic effect of gabapentin
时间窗: in 3 months after initiation of the gabapentin treatment
The decrease of the incidence of chronic neuropathic pain in 3 months after initiation of the gabapentin treatment in 3 months after initiation of the gabapentin treatment
次要结局
- The decrease of the consumption of rescue medication(in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
- The decrease of the incidence of chronic neuropathic pain(in 6., 9. and 12. months after initiation of the gabapentin treatment)
- Quality of life(in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
- Absolute and percentage change in average pain(in 3., 6., 9. and 12. months)
- The number of painful episodes(in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
研究者
研究点 (1)
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