<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/NCT03016364</url>
  </required_header>
  <id_info>
    <org_study_id>CFH2016-3-4025</org_study_id>
    <nct_id>NCT03016364</nct_id>
  </id_info>
  <brief_title>Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain</brief_title>
  <official_title>Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <brief_summary>
    <textblock>
      The purpose of this trial is to determine whether Application (APP) would help clinical&#xD;
      doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced&#xD;
      patients with cancer pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Numerical Pain Rating Scale</measure>
    <time_frame>upto 8 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pain</condition>
  <condition>Physicians</condition>
  <condition>Oxycodone</condition>
  <arm_group>
    <arm_group_label>APP in dosage adjustment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Through the guidance of APP software, clinical doctors try to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>APP software</intervention_name>
    <description>A software used to by physicians to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain</description>
    <arm_group_label>APP in dosage adjustment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a histologically confirmed diagnosis of Cancer or Sarcoma&#xD;
&#xD;
          -  advanced patients with severe cancer pain(score &gt;3)&#xD;
&#xD;
          -  having used or expected to use the Oxycodone Hydrochloride Prolonged-release Tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergic to Oxycodone Hydrochloride Prolonged-release Tablets, or other reasons&#xD;
             (determined by clinical doctors) unable to use the Opioids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Peng Liu, MD</last_name>
    <phone>8610-87788405</phone>
    <email>13910216310@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peng Liu, MD</last_name>
      <phone>8610-87788507</phone>
      <email>13910216310@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Peng Liu</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <!-- 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/NCT03016364
org study id: CFH2016-3-4025
nct id: NCT03016364
lead sponsor: 
The purpose of this trial is to determine whether Application (APP) would help clinical
      doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced
      patients with cancer pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Numerical Pain Rating Scale
time frame: upto 8 months
arm group label: APP in dosage adjustment
arm group type: Experimental
description: Through the guidance of APP software, clinical doctors try to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain.
intervention type: Device
intervention name: APP software
description: A software used to by physicians to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain
arm group label: APP in dosage adjustment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Peng Liu, MD
phone: 8610-87788405
email: 13910216310@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Peng Liu
investigator title: Attending Physician