Status:
WITHDRAWN
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
Lead Sponsor:
Masaryk University
Conditions:
Chronic Pain Due to Trauma
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03255330
Start Date
October 1 2017
End Date
August 1 2020
Last Update
March 7 2019
Active Locations (1)
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1
Fakultní nemocnice Brno
Brno, Czechia