Back to resultsThe Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma (GabaNeuBol)
Primary Purpose
Chronic Pain Due to Trauma, Spinal Cord Injuries
Status
Withdrawn
Phase
Phase 3
Locations
Czechia
Study Type
Interventional
Intervention
Gabapentin
Metamizol
Tramadol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain Due to Trauma
Eligibility Criteria
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
Sites / Locations
- Fakultní nemocnice Brno
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm G1800
G0
Arm Description
administration of gabapentin with a gradual increasing dose of up to 1800 mg / day
Standardized medical treatment of central neuropathic pain: metamizole, tramadol
Outcomes
Primary Outcome Measures
Assessment the analgesic effect of gabapentin
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
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
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
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
Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months
Quality of life
Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03255330
Brief Title
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
Acronym
GabaNeuBol
Official Title
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
no participant enrolled
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masaryk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Due to Trauma, Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm G1800
Arm Type
Experimental
Arm Description
administration of gabapentin with a gradual increasing dose of up to 1800 mg / day
Arm Title
G0
Arm Type
Active Comparator
Arm Description
Standardized medical treatment of central neuropathic pain: metamizole, tramadol
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gabapentinum
Intervention Description
Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
Intervention Type
Drug
Intervention Name(s)
Metamizol
Intervention Description
Standardized treatment
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Standardized treatment
Primary Outcome Measure Information:
Title
Assessment the analgesic effect of gabapentin
Description
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
Time Frame
in 3 months after initiation of the gabapentin treatment
Secondary Outcome Measure Information:
Title
The decrease of the incidence of chronic neuropathic pain
Description
The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment
Time Frame
in 6., 9. and 12. months after initiation of the gabapentin treatment
Title
The number of painful episodes
Description
The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
Time Frame
in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Title
The decrease of the consumption of rescue medication
Description
The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Time Frame
in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Title
Absolute and percentage change in average pain
Description
Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months
Time Frame
in 3., 6., 9. and 12. months
Title
Quality of life
Description
Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R
Time Frame
in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fakultní nemocnice Brno
City
Brno
Country
Czechia
12. IPD Sharing Statement
Learn more about this trial
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
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