The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma (GabaNeuBol)

Masaryk University

Status and phase: Withdrawn; Phase 3

Conditions: Spinal Cord Injuries; Chronic Pain Due to Trauma

Treatments: Drug: Gabapentin; Drug: Metamizol; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT03255330

GNB-2015

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm G1800

Experimental group

Description:

administration of gabapentin with a gradual increasing dose of up to 1800 mg / day

Treatment:

Drug: Gabapentin

G0

Active Comparator group

Description:

Standardized medical treatment of central neuropathic pain: metamizole, tramadol

Treatment:

Drug: Metamizol

Drug: Tramadol