The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
NCT ID: NCT03255330
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-10-31
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm G1800
administration of gabapentin with a gradual increasing dose of up to 1800 mg / day
Gabapentin
Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
G0
Standardized medical treatment of central neuropathic pain: metamizole, tramadol
Metamizol
Standardized treatment
Tramadol
Standardized treatment
Interventions
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Gabapentin
Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
Metamizol
Standardized treatment
Tramadol
Standardized treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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 from 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
18 Years
65 Years
ALL
No
Sponsors
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Masaryk University
OTHER
Responsible Party
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Locations
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Fakultní nemocnice Brno
Brno, , Czechia
Countries
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Other Identifiers
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GNB-2015
Identifier Type: -
Identifier Source: org_study_id
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