Chronic neuropathic pain in patients after spinal cord trauma
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Gabapentinum
Other descriptive name: GABAPENTIN
Concentration unit: mg milligram(s)
Sponsors
Masarykova univerzita
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment the analgesic effect of gabapentin (up to a maximum dose of 1800 mg) in chronic neuropathic pain in the 3rd month after the start of treatment compared to the group of patients without anticonvulsant medication; Secondary Objective: To evaluate analgesic effects of gabapentin (up to a maximum dose of 1800 mg) in chronic neuropathic pain in 6, 9 and 12 months compared to patients with no anticonvulsant medication The incidence of chronic neuropathic pain in patients after spinal cord trauma taking gabapentin versus patients without anticonvulsant medication The estimate quality of life, evaluation of neurological pain and mental condition (PainDETECT, SQUALA and SCL-R) in patients after spinal cord trauma taking gabapentin and patients without anticonvulsant medication To evaluate safety and tolerability of gabapentin treatment ;Primary end point(s): The decrease of the incidence of chronic neuropathic pain in 3 months after initiation of the gabapentin treatment;Timepoint(s) of evaluation of this end point: in 3 months after initiation of the gabapentin treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment 2. The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment) 3. The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment 4. Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months 5. Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R (in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment) ;Timepoint(s) of evaluation of this end point: In week 1 and 3., 6., 9. and 12. months after initiation of the gabapentin treatment | — |
Countries
Czech Republic
Contacts
Public ContactCentrum pro klinická hodnocení
Masarykova univerzita - Lékarská fakulta
Outcome results
None listed