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

NCT03255330 | Withdrawn Phase 3

• 1 other identifier: GNB-2015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain Due to Trauma; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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

  in 3 months after initiation of the gabapentin treatment

Secondary Outcomes (5)

• 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 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

• Quality of life

  in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment

Study Arms (2)

Arm G1800

EXPERIMENTAL

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

Drug: Gabapentin

G0

ACTIVE COMPARATOR

Standardized medical treatment of central neuropathic pain: metamizole, tramadol

Drug: Metamizol; Drug: Tramadol

Interventions

Gabapentin DRUG

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

Also known as: Gabapentinum

Arm G1800

Metamizol DRUG

Standardized treatment

G0

Tramadol DRUG

Standardized treatment

G0

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (1)

Fakultní nemocnice Brno

Brno, Czechia

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Gabapentin; Dipyrone; Tramadol

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 21, 2017
• Study Start: October 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

CZ (1)