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

Spinal Cord Injuries Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03255330
• Other study ID #: GNB-2015
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 2017
• Est. completion date: August 2020

Study information

• Verified date: March 2019
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Due to Trauma
• Neuralgia
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• Gabapentin
Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
• Metamizol
Standardized treatment
• Tramadol
Standardized treatment

Locations

Country	Name	City	State
Czechia	Fakultní nemocnice Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	in 6., 9. and 12. months after initiation of the gabapentin treatment
Secondary	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)	in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Secondary	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	in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Secondary	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	in 3., 6., 9. and 12. months
Secondary	Quality of life	Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R	in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment