<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/NCT04401735</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBHPAIN</org_study_id>
    <nct_id>NCT04401735</nct_id>
  </id_info>
  <brief_title>Effects and Safety of Epidural PDRN vs. Placebo</brief_title>
  <official_title>Effects and Safety of PDRN (Polydeoxyribonucleotide) for Patient With Lumbar Spinal Stenosis Compared With Normal Saline in Randomized Placebo-Controlled Comparative Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, randomized, double-blind clinical study to assess the clinical&#xD;
      application and outcomes with epidural PDRN versus Normal saline injection in patients with&#xD;
      spinal stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who are already planning to receive an Transforaminal epidural block from their&#xD;
      clinician will be approached by study members on the day of their injection. If enrolled, the&#xD;
      patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and&#xD;
      degree of pain relief from the injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2020</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analogue scale(VAS)</measure>
    <time_frame>12 weeks post - injection</time_frame>
    <description>This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual analogue scale(VAS)</measure>
    <time_frame>4, 8 weeks post - injection</time_frame>
    <description>This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI(Clinicians Global Impression)</measure>
    <time_frame>4, 8 weeks post - injection</time_frame>
    <description>7 point scale that requires the clinician to assess how much the patient's illness has improved(grade 0) or worsened(grade 7) relative to a baseline state at the beginning of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treadmill test</measure>
    <time_frame>8 weeks post - injection</time_frame>
    <description>walking distance</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Spinal Stenosis Lumbar</condition>
  <arm_group>
    <arm_group_label>Polydeoxyribonucleotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Polydeoxyribonucleotide(PDRN) 5.625mg/3ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polydeoxyribonucleotide, Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Normal saline)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polydeoxyribonucleotides</intervention_name>
    <description>PDRN injection to epidural space</description>
    <arm_group_label>Polydeoxyribonucleotide</arm_group_label>
    <arm_group_label>Polydeoxyribonucleotide, Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Polydeoxyribonucleotide, Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Adults aged between 19-80 years old&#xD;
&#xD;
          -  2. Radiological confirmation of spinal stenosis on MRI&#xD;
&#xD;
          -  3. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis&#xD;
&#xD;
          -  4. Follow-up possible during 3 months the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to comply fully with the protocol, including treatment, follow-up or study&#xD;
             procedures&#xD;
&#xD;
          -  pregnant or feeding women&#xD;
&#xD;
          -  Alcohol/drug abuse&#xD;
&#xD;
          -  Anticoagulant medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lee pyongbok</last_name>
    <phone>82-2-787-7495</phone>
    <email>painfree@snubh.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul national university Bundang hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Kyoung-ki-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eunjoo Choi, MD</last_name>
      <phone>82-31-787-6572</phone>
      <email>ejchoi7956@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Pyung Bok Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Pyung-Bok Lee</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_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/NCT04401735
org study id: SNUBHPAIN
nct id: NCT04401735
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single-center, randomized, double-blind clinical study to assess the clinical
      application and outcomes with epidural PDRN versus Normal saline injection in patients with
      spinal stenosis.
Patients who are already planning to receive an Transforaminal epidural block from their
      clinician will be approached by study members on the day of their injection. If enrolled, the
      patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and
      degree of pain relief from the injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: visual analogue scale(VAS)
time frame: 12 weeks post - injection
description: This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)
measure: visual analogue scale(VAS)
time frame: 4, 8 weeks post - injection
description: This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)
measure: CGI(Clinicians Global Impression)
time frame: 4, 8 weeks post - injection
description: 7 point scale that requires the clinician to assess how much the patient's illness has improved(grade 0) or worsened(grade 7) relative to a baseline state at the beginning of the intervention.
measure: treadmill test
time frame: 8 weeks post - injection
description: walking distance
arm group label: Polydeoxyribonucleotide
arm group type: Experimental
description: Polydeoxyribonucleotide(PDRN) 5.625mg/3ml
arm group label: Polydeoxyribonucleotide, Placebo
arm group type: Experimental
description: Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (Normal saline)
intervention type: Drug
intervention name: Polydeoxyribonucleotides
description: PDRN injection to epidural space
arm group label: Polydeoxyribonucleotide
arm group label: Polydeoxyribonucleotide, Placebo
intervention type: Drug
intervention name: Normal saline
description: Normal saline
arm group label: Placebo
arm group label: Polydeoxyribonucleotide, Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lee pyongbok
phone: 82-2-787-7495
email: painfree@snubh.org
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Pyung-Bok Lee
investigator title: Principal Investigator
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic