<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/NCT03813277</url>
  </required_header>
  <id_info>
    <org_study_id>3005031</org_study_id>
    <nct_id>NCT03813277</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU</brief_title>
  <acronym>Pedrux</acronym>
  <official_title>Open Clinical Trial to Evaluate Safety, Tolerability, and Efficacy of Dexdor for Sedation in Paediatric Patients in Intensive Care Settings. Multi-centre Trial in Russia for Marketing Registration of Dexdor.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</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>
      Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in&#xD;
      paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing&#xD;
      registration of Dexdor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric&#xD;
      experiences in the literature are in the form of small studies and case reports.&#xD;
&#xD;
      Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical&#xD;
      situations. Based on literature analysis, dexmedetomidine may be potentially used in the&#xD;
      intensive care unit in pediatric patients who require sedation, either breath spontaneously&#xD;
      or require mechanical ventilation.&#xD;
&#xD;
      Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for&#xD;
      therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to&#xD;
      further evaluate its safety and efficacy in all age ranges.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients</measure>
    <time_frame>max 5 days</time_frame>
    <description>Time spent in target sedation range (RASS score )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients</measure>
    <time_frame>max 5 days</time_frame>
    <description>Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wake-up/discontinuation of sedation (if applicable)</measure>
    <time_frame>max 5 days</time_frame>
    <description>Wake-up/discontinuation of sedation (if applicable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to extubation.</measure>
    <time_frame>max 5 days</time_frame>
    <description>Extubation assessment (if applicable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first rescue medication</measure>
    <time_frame>max 5 days</time_frame>
    <description>Time to first rescue medication</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>max 5 days</time_frame>
    <description>Clinical safety of dexdor infusion</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>ICU Sedation</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexmedetomidine 100microg/ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>infusion</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age from 12 to 17 years;&#xD;
&#xD;
          2. Clinical need for prolonged (&gt;24h) light to moderate sedation in patients with&#xD;
             spontaneous or artificial ventilation&#xD;
&#xD;
          3. Negative urine pregnancy test (for female patients);&#xD;
&#xD;
          4. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute severe intracranial or spinal neurological disorder due to vascular causes,&#xD;
             infection, intracranial expansion or injury; any other disorder where sedation&#xD;
             assessment is not reliable due to any neurological conditions;&#xD;
&#xD;
          2. Uncompensated acute circulatory failure;&#xD;
&#xD;
          3. Severe hypotension or hypertension&#xD;
&#xD;
          4. Severe bradycardia or tachycardia&#xD;
&#xD;
          5. A/V-conduction block II-III;&#xD;
&#xD;
          6. Severe hepatic impairment&#xD;
&#xD;
          7. Loss of hearing or vision, or any other condition which would significantly interfere&#xD;
             with the collection of study data;&#xD;
&#xD;
          8. Use of centrally acting alfa-2 agonists or antagonists in the period less than 5x&#xD;
             halflife between drug discontinuation and the time of randomisation;&#xD;
&#xD;
          9. Patients who have or are expected to have treatment withdrawn or withheld due to poor&#xD;
             prognosis&#xD;
&#xD;
         10. Patients receiving sedatives for therapeutic indications (e.g. epilepsy);&#xD;
&#xD;
         11. Patients allergic to dexmedetomidine and rescue medications&#xD;
&#xD;
         12. Hemodialysis and peritoneal dialysis;&#xD;
&#xD;
         13. Those requiring deep sedation or neuromuscular blocking agents;&#xD;
&#xD;
         14. Burn injuries and other injuries requiring regular anaesthesia or surgery;&#xD;
&#xD;
         15. History / family history of malignant hyperthermia;&#xD;
&#xD;
         16. Patients unlikely to be weaned from the ventilator during the study;&#xD;
&#xD;
         17. Patients with early-onset ventilator-associated pneumonia;&#xD;
&#xD;
         18. Any investigational drug within the preceding 30 days;&#xD;
&#xD;
         19. Any other reason which in the investigator's opinion would make it detrimental for the&#xD;
             subject to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andershan Lekmahnov, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>State Federal-Funded Educational Institution of</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>State Federal-Funded Educational Institution of</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03813277
org study id: 3005031
nct id: NCT03813277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in
      paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing
      registration of Dexdor
Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric
      experiences in the literature are in the form of small studies and case reports.

      Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical
      situations. Based on literature analysis, dexmedetomidine may be potentially used in the
      intensive care unit in pediatric patients who require sedation, either breath spontaneously
      or require mechanical ventilation.

      Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for
      therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to
      further evaluate its safety and efficacy in all age ranges.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients
time frame: max 5 days
description: Time spent in target sedation range (RASS score )
measure: Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients
time frame: max 5 days
description: Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication)
measure: Wake-up/discontinuation of sedation (if applicable)
time frame: max 5 days
description: Wake-up/discontinuation of sedation (if applicable)
measure: Time to extubation.
time frame: max 5 days
description: Extubation assessment (if applicable).
measure: Time to first rescue medication
time frame: max 5 days
description: Time to first rescue medication
measure: Safety and tolerability
time frame: max 5 days
description: Clinical safety of dexdor infusion
arm group label: Dexmedetomidine
arm group type: Experimental
description: Dexmedetomidine 100microg/ml
intervention type: Drug
intervention name: Dexmedetomidine
description: infusion
arm group label: Dexmedetomidine
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Andershan Lekmahnov, Prof
role: Principal Investigator
affiliation: State Federal-Funded Educational Institution of
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Dexmedetomidine
sharing ipd: No