xml: <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/NCT05962294</url>
    </required_header>
    <id_info>
      <org_study_id>TA2023-246</org_study_id>
      <nct_id>NCT05962294</nct_id>
    </id_info>
    <brief_title>Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain</brief_title>
    <official_title>The Efficacy and Safety of Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Moderate to Severe Cancer Pain：A Multicenter Real World Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Henan Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Henan Cancer Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this real world study is to observe the efficacy and safety of Oxycodone&#xD;
        Hydrochloride Sustained-release Tablets in the treatment of moderate to severe cancer pain&#xD;
        participants in real clinical practice.&#xD;
  &#xD;
        After entering the study, participants will take Oxycodone Hydrochloride Sustained-release&#xD;
        Tablets. The investigators need to observe and record relevant data, and finally analyze and&#xD;
        summarize the data to understand the efficacy and safety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, single arm, multicenter real world study, the investigators&#xD;
        didn't set up a control group. After the participant is enrolled, the participant will enter&#xD;
        a 14 day treatment cycle, where the medication will be proportionally converted into&#xD;
        Oxycodone Hydrochloride Sustained-release Tablets. The daily medication dose will be adjusted&#xD;
        based on the number of pain outbreaks and pain scores (According to the drug increment&#xD;
        principle of NCCN), and various information (Daily oxycodone dose, average pain score,&#xD;
        minimal pain score, most severe pain score, number of breakout pain, name of rescue drugs,&#xD;
        number of rescue, heart rate, blood pressure, respiratory rate, SPO2, combination of drugs,&#xD;
        pain control satisfaction, etc) about the participant's medication will be recorded. The&#xD;
        participant will not be limited to whether to combine medication. Observe the efficacy and&#xD;
        safety of Oxycodone Hydrochloride Sustained-release Tablets.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Mean difference in pain intensity after treatment</measure>
      <time_frame>From the 1st to 14th day of treatment</time_frame>
      <description>Use the Numeric Rating Scale（NRS, 0 to 10 points, lower scores indicate better pain control） to evaluate the average pain score per day over the past 24 hours. Calculate the daily difference in pain intensity (PID) by subtracting the daily NRS score from the baseline NRS score. Divide the sum of PID on days 1 to 14 by 14 to obtain the mean difference in pain intensity (MPID).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The proportion of patients with effective pain relief</measure>
      <time_frame>From the 1st to 14th day of treatment</time_frame>
      <description>Effective pain relief is defined as a decrease of 30% or more in average pain intensity from day 1 to day 14 compared to the baseline period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The proportion of patients with effective pain control</measure>
      <time_frame>From the 1st to 14th day of treatment</time_frame>
      <description>The proportion of patients whose pain is under control. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time for the patient's pain to be effectively controlled</measure>
      <time_frame>From the 1st to 14th day of treatment</time_frame>
      <description>The time from the beginning of treatment to effective pain control for patients. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The improvement of patient symptoms</measure>
      <time_frame>On the 3rd, 7th, and 14th days after treatment</time_frame>
      <description>We use the Brief Pain Inventory (BPI) to evaluate the improvement of patient symptoms. There are a total of 7 projects, with each project scoring 0-10 points. The lower the score, the more significant the improvement in symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The satisfaction with pain control</measure>
      <time_frame>On the 3rd, 7th, and 14th days after treatment</time_frame>
      <description>0-10 points (the higher the score, the higher the satisfaction), participants can rate treatment satisfaction based on the efficacy and safety of the experimental drug. It's the patient's subjective perception of pain control.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">916</enrollment>
    <condition>Cancer Pain</condition>
    <condition>Real-world Study</condition>
    <condition>Oxycodone</condition>
    <eligibility>
      <study_pop>
        <textblock>
          This study is a prospective, single arm, multicenter real-world study that only needs to&#xD;
          meet the requirements of age, disease type, drug dosage, and no severe mental illness in&#xD;
          the study population&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Voluntarily sign an informed consent form;&#xD;
  &#xD;
            2. Age ≥ 18 years old;&#xD;
  &#xD;
            3. Patients with moderate to severe (NRS ≥ 4 points) cancer pain;&#xD;
  &#xD;
            4. Patients with oral equivalent Oxycodone Hydrochloride Sustained-release Tablets ≥&#xD;
               80mg/d.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Patients with severe mental illness who cannot cooperate with follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Suxia Luo, Doctor</last_name>
      <phone>+86 18638553211</phone>
      <email>luosxrm@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Henan Cancer Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Suxia Luo, Doctor</last_name>
        <phone>+8618638553211</phone>
        <email>luosxrm@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Oxycodone Hydrochloride Sustained-release Tablets</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cancer Pain</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962294
  org study id: TA2023-246
  nct id: NCT05962294
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this real world study is to observe the efficacy and safety of Oxycodone
        Hydrochloride Sustained-release Tablets in the treatment of moderate to severe cancer pain
        participants in real clinical practice.
  
        After entering the study, participants will take Oxycodone Hydrochloride Sustained-release
        Tablets. The investigators need to observe and record relevant data, and finally analyze and
        summarize the data to understand the efficacy and safety.
  This study is a prospective, single arm, multicenter real world study, the investigators
        didn't set up a control group. After the participant is enrolled, the participant will enter
        a 14 day treatment cycle, where the medication will be proportionally converted into
        Oxycodone Hydrochloride Sustained-release Tablets. The daily medication dose will be adjusted
        based on the number of pain outbreaks and pain scores (According to the drug increment
        principle of NCCN), and various information (Daily oxycodone dose, average pain score,
        minimal pain score, most severe pain score, number of breakout pain, name of rescue drugs,
        number of rescue, heart rate, blood pressure, respiratory rate, SPO2, combination of drugs,
        pain control satisfaction, etc) about the participant's medication will be recorded. The
        participant will not be limited to whether to combine medication. Observe the efficacy and
        safety of Oxycodone Hydrochloride Sustained-release Tablets.
  observational model: Ecologic or Community
  time perspective: Prospective
  measure: Mean difference in pain intensity after treatment
  time frame: From the 1st to 14th day of treatment
  description: Use the Numeric Rating Scale（NRS, 0 to 10 points, lower scores indicate better pain control） to evaluate the average pain score per day over the past 24 hours. Calculate the daily difference in pain intensity (PID) by subtracting the daily NRS score from the baseline NRS score. Divide the sum of PID on days 1 to 14 by 14 to obtain the mean difference in pain intensity (MPID).
  measure: The proportion of patients with effective pain relief
  time frame: From the 1st to 14th day of treatment
  description: Effective pain relief is defined as a decrease of 30% or more in average pain intensity from day 1 to day 14 compared to the baseline period.
  measure: The proportion of patients with effective pain control
  time frame: From the 1st to 14th day of treatment
  description: The proportion of patients whose pain is under control. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.
  measure: The time for the patient's pain to be effectively controlled
  time frame: From the 1st to 14th day of treatment
  description: The time from the beginning of treatment to effective pain control for patients. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.
  measure: The improvement of patient symptoms
  time frame: On the 3rd, 7th, and 14th days after treatment
  description: We use the Brief Pain Inventory (BPI) to evaluate the improvement of patient symptoms. There are a total of 7 projects, with each project scoring 0-10 points. The lower the score, the more significant the improvement in symptoms.
  measure: The satisfaction with pain control
  time frame: On the 3rd, 7th, and 14th days after treatment
  description: 0-10 points (the higher the score, the higher the satisfaction), participants can rate treatment satisfaction based on the efficacy and safety of the experimental drug. It's the patient's subjective perception of pain control.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Suxia Luo, Doctor
  phone: +86 18638553211
  email: luosxrm@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Cancer Pain