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

Phase 3

Withdrawn

• Conditions: Spinal Cord Injuries; Chronic Pain Due to Trauma
• Interventions: Drug: Gabapentin; Drug: Metamizol; Drug: Tramadol

• Registration Number: NCT03255330
• Lead Sponsor: Masaryk University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Study Start: 2017-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07
• Primary Completion: 2020-02
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm G1800	Gabapentin	administration of gabapentin with a gradual increasing dose of up to 1800 mg / day
G0	Metamizol	Standardized medical treatment of central neuropathic pain: metamizole, tramadol
G0	Tramadol	Standardized medical treatment of central neuropathic pain: metamizole, tramadol

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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)

Trial Locations

Locations (1)

Fakultní nemocnice Brno; 🇨🇿 Brno, Czechia