<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03255330</url>
  </required_header>
  <id_info>
    <org_study_id>GNB-2015</org_study_id>
    <nct_id>NCT03255330</nct_id>
  </id_info>
  <brief_title>The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma</brief_title>
  <acronym>GabaNeuBol</acronym>
  <official_title>The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masaryk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masaryk University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study of the effect of gabapentin used as a preemptive to the emergence and development&#xD;
      chronic neuropathic pain in patients after spinal cord trauma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no participant enrolled&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment the analgesic effect of gabapentin</measure>
    <time_frame>in 3 months after initiation of the gabapentin treatment</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The decrease of the incidence of chronic neuropathic pain</measure>
    <time_frame>in 6., 9. and 12. months after initiation of the gabapentin treatment</time_frame>
    <description>The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of painful episodes</measure>
    <time_frame>in 3., 6., 9. and 12. months after initiation of the gabapentin treatment</time_frame>
    <description>The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The decrease of the consumption of rescue medication</measure>
    <time_frame>in 3., 6., 9. and 12. months after initiation of the gabapentin treatment</time_frame>
    <description>The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute and percentage change in average pain</measure>
    <time_frame>in 3., 6., 9. and 12. months</time_frame>
    <description>Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment</time_frame>
    <description>Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Pain Due to Trauma</condition>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Arm G1800</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administration of gabapentin with a gradual increasing dose of up to 1800 mg / day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G0</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standardized medical treatment of central neuropathic pain: metamizole, tramadol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present</description>
    <arm_group_label>Arm G1800</arm_group_label>
    <other_name>Gabapentinum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metamizol</intervention_name>
    <description>Standardized treatment</description>
    <arm_group_label>G0</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol</intervention_name>
    <description>Standardized treatment</description>
    <arm_group_label>G0</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women, age 18 - 65 years&#xD;
&#xD;
          2. Signed written informed consent&#xD;
&#xD;
          3. Patients after complete/non-complete spinal lesion, after surgery&#xD;
&#xD;
          4. Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone&#xD;
             fragment, a disk, a translation spinal canal)&#xD;
&#xD;
          5. Patient willing and able to comply with the study protocol&#xD;
&#xD;
          6. Male and females with a highly effective method of birth control plus an additional&#xD;
             barrier method&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with spinal cord lesion ischemic etiology&#xD;
&#xD;
          2. Pregnant women, nursing or childbearing age with a positive pregnancy test input&#xD;
&#xD;
          3. Patients unable or unwilling to comply with the study protocol&#xD;
&#xD;
          4. Acute pancreatitis in 1 year from the start of the study&#xD;
&#xD;
          5. Chronic pancreatitis in the case history&#xD;
&#xD;
          6. Active or uncontrolled infectious diseases&#xD;
&#xD;
          7. Hypersensitivity to any component of the investigational product&#xD;
&#xD;
          8. Active autoimmune disease&#xD;
&#xD;
          9. Serious neurological disease with the incidence chronic neuropathic pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fakultní nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dipyrone</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Tramadol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03255330
org study id: GNB-2015
nct id: NCT03255330
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study of the effect of gabapentin used as a preemptive to the emergence and development
      chronic neuropathic pain in patients after spinal cord trauma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment the analgesic effect of gabapentin
time frame: in 3 months after initiation of the gabapentin treatment
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
measure: The decrease of the incidence of chronic neuropathic pain
time frame: in 6., 9. and 12. months after initiation of the gabapentin treatment
description: The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment
measure: The number of painful episodes
time frame: in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
description: The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
measure: The decrease of the consumption of rescue medication
time frame: in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
description: The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
measure: Absolute and percentage change in average pain
time frame: in 3., 6., 9. and 12. months
description: Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months
measure: Quality of life
time frame: in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment
description: Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R
arm group label: Arm G1800
arm group type: Experimental
description: administration of gabapentin with a gradual increasing dose of up to 1800 mg / day
arm group label: G0
arm group type: Active Comparator
description: Standardized medical treatment of central neuropathic pain: metamizole, tramadol
intervention type: Drug
intervention name: Gabapentin
description: Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
arm group label: Arm G1800
other name: Gabapentinum
intervention type: Drug
intervention name: Metamizol
description: Standardized treatment
arm group label: G0
intervention type: Drug
intervention name: Tramadol
description: Standardized treatment
arm group label: G0
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Neuralgia
mesh term: Chronic Pain
mesh term: Wounds and Injuries
mesh term: Dipyrone
mesh term: Gabapentin
mesh term: Tramadol