Chronic Pain Due to TraumaPhase 3GabaNeuBolNCT03255330
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
A Phase 3 study testing Gabapentin, Metamizol and Tramadol in people with Chronic Pain Due to Trauma and Spinal Cord Injuries, run by Masaryk University at 1 site in Czechia.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain Due to Trauma, Spinal Cord Injuries
- What is being tested?
- Gabapentin, Metamizol and Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCzechia
- Study dates
- Oct 2017to Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Hypersensitivity to any component of the investigational product
- Active autoimmune disease
- Serious neurological disease with the incidence chronic neuropathic pain
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Gabapentin, Metamizol, Tramadol
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Gabapentinum
Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
MetamizolDrug
Standardized treatment
TramadolDrug
Standardized treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm G1800 | Experimental | administration of gabapentin with a gradual increasing dose of up to 1800 mg / day Receives: Drug: Gabapentin |
| G0 | Active comparator | Standardized medical treatment of central neuropathic pain: metamizole, tramadol Receives: Drug: Metamizol; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: in 3 months after initiation of the gabapentin treatment
Secondary outcomes (5)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study startOct 2017 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: no participant enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255330
- Sponsor's protocol ID
- GNB-2015
- Acronym
- GabaNeuBol
- Status last verified
- Mar 2019
- First submitted
- 15 Aug 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
- ClinicalTrials.gov ID
- NCT03255330
- Acronym / sponsor ID
- GabaNeuBol / GNB-2015
- Conditions
- Chronic Pain Due to Trauma, Spinal Cord Injuries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participant enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm G1800 | Experimental | Drug: Gabapentinadministration of gabapentin with a gradual increasing dose of up to 1800 mg / day |
| G0 | Active comparator | Drug: Metamizol, Drug: TramadolStandardized medical treatment of central neuropathic pain: metamizole, tramadol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: GabapentinumGabapentin will be given approximately 3 months until no chronic neuropathic pain is present | Drug | Arm G1800 |
| MetamizolStandardized treatment | Drug | G0 |
| TramadolStandardized treatment | Drug | G0 |
Primary outcome
Assessment the analgesic effect of gabapentin
Time frame: 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
5 secondary outcomes
The decrease of the incidence of chronic neuropathic pain
Time frame: in 6., 9. and 12. months after initiation of the gabapentin treatment
The number of painful episodes
Time frame: in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
The decrease of the consumption of rescue medication
Time frame: in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Absolute and percentage change in average pain
Time frame: in 3., 6., 9. and 12. months
Quality of life
Time frame: in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin, Metamizol and Tramadol in people with Chronic Pain Due to Trauma and Spinal Cord Injuries, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the analgesic effect of gabapentin (time frame: in 3 months after initiation of the gabapentin treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.