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

Sponsor

Masaryk University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03255330

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Due to Trauma Spinal Cord Injuries	Drug: Gabapentin Drug: Metamizol Drug: Tramadol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2017

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm G1800 administration of gabapentin with a gradual increasing dose of up to 1800 mg / day	Drug: Gabapentin Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present Other Names: Gabapentinum
Active Comparator: G0 Standardized medical treatment of central neuropathic pain: metamizole, tramadol	Drug: Metamizol Standardized treatment Drug: Tramadol Standardized treatment

Arm

Intervention/Treatment

Experimental: Arm G1800

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

Drug: Gabapentin

Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present

Other Names:

Gabapentinum

Active Comparator: G0

Standardized medical treatment of central neuropathic pain: metamizole, tramadol

Drug: Metamizol

Standardized treatment

Drug: Tramadol

Standardized treatment

Outcome Measures

Primary Outcome Measures

Assessment the analgesic effect of gabapentin [in 3 months after initiation of the gabapentin treatment]
The decrease of the incidence of chronic neuropathic pain in 3 months after initiation of the gabapentin treatment in 3 months after initiation of the gabapentin treatment

Secondary Outcome Measures

The decrease of the incidence of chronic neuropathic pain [in 6., 9. and 12. months after initiation of the gabapentin treatment]
The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment
The number of painful episodes [in 3., 6., 9. and 12. months after initiation of the gabapentin treatment]
The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
The decrease of the consumption of rescue medication [in 3., 6., 9. and 12. months after initiation of the gabapentin treatment]
The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Absolute and percentage change in average pain [in 3., 6., 9. and 12. months]
Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months
Quality of life [in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment]
Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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