The effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma - GabaNeuBol

Masarykova univerzita0 个研究点目标入组 120 人开始时间: 2017年1月18日最近更新: 2019年4月30日

试验速览

暂无简介。

•1. Men and women, age 18 – 65 years
•2. Signed written informed consent
•3. Patients after complete/non-complete spinal lesion, after surgery
•4. Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal)
•5. Patient willing and able to comply with the study protocol
•6. Male and females with a highly effective method of birth control plus an additional barrier method
•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 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1. Patients with spinal cord lesion ischemic etiology
•2. Pregnant women, nursing or childbearing age with a positive pregnancy test input
•3. Patients unable or unwilling to comply with the study protocol
•4. Acute pancreatitis in 1 year to the start of the study
•5. Chronic pancreatitis in the case history
•6. Active or uncontrolled infectious diseases
•7. Hypersensitivity to any component of the investigational product
•8. Active autoimmune disease
•9. Serious neurological disease with the incidence chronic neuropathic pain
•10. Age > 65
•11. Diabetes mellitus,
•12. Liver disease ALT/ AST 5 times upper limit of normal (ULN)
•13. Kidney disease clearance =80 ml/min
•14. Gastrointestinal disease threatening the absorption in the case history
•15. The presence of a mental disease, which could be an obstacle to progress in accordance with the study protocol
•16. Chronic alcohol abuse
•17. Chronic drug abuse

发起方