<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/NCT01675622</url>
  </required_header>
  <id_info>
    <org_study_id>OXYC10-CN-303</org_study_id>
    <nct_id>NCT01675622</nct_id>
  </id_info>
  <brief_title>Immediate-Release Oxycodone Capsules Study in Cancer Pain</brief_title>
  <official_title>A Comparative Study of Immediate-Release Oxycodone Capsules Versus Immediate-Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mundipharma (China) Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mundipharma (China) Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus&#xD;
      morphine immediate-release tablets in the treatment of cancer pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules&#xD;
      versus morphine immediate-release tablets in the treatment of cancer pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2011</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical Rating Scale (NRS)</measure>
    <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
    <description>The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Average Dose of Study Medicine Used During Double Blind Treatment Period</measure>
    <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
    <description>the average dose of study medicine used during double blind treatment period between the two treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period</measure>
    <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
    <description>The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times of Breakthrough Pain Occurrence</measure>
    <time_frame>Within 8 days after baseline</time_frame>
    <description>the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessments of Satisfaction for Pain Management</measure>
    <time_frame>baseline up to 19-22 days (open label treatment)</time_frame>
    <description>the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Titrations</measure>
    <time_frame>baseline up to 1-3 days(double blind period)</time_frame>
    <description>the average times to change the dose in order to find the proper dose between two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment</measure>
    <time_frame>baseline up to 19-22 days (open label treatment)</time_frame>
    <description>The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Total Dose of Rescue Medicine for Breakthrough Pain.</measure>
    <time_frame>baseline up to 22 days (double blind period)</time_frame>
    <description>the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of Pain Relief Within 24hrs After Treatment</measure>
    <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
    <description>Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment</measure>
    <time_frame>baseline up to 19-22 days (open label treatment)</time_frame>
    <description>For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">242</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Oxycodone Capsules for cancer pain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine tablets for cancer pain</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
    <arm_group_label>Oxycodone Capsules for cancer pain</arm_group_label>
    <other_name>No other name in this study</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
    <arm_group_label>Morphine tablets for cancer pain</arm_group_label>
    <other_name>No other name</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of either sex aged 18 to 80 years inclusive, who with cancers of all type.&#xD;
&#xD;
          2. Patients with moderate to severe cancer pain, whose pain intensity Numeric Rating&#xD;
             Scale ≥4.&#xD;
&#xD;
          3. Patients who can understand and are able to complete Numeric Rating Scale and Brief&#xD;
             Pain Inventory assessment.&#xD;
&#xD;
          4. Patients who have given written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are pregnant, or lactating.&#xD;
&#xD;
          2. Patients who are unable to manage their pain effectively with opioids.&#xD;
&#xD;
          3. Patient who need ≥120mg morphine or equivalent for treatment of pain at time of study&#xD;
             entry;&#xD;
&#xD;
          4. Patients who are receiving chemotherapy, or still under the responsive period of&#xD;
             chemotherapy (patients who are at the interval period of chemotherapy can be enrolled&#xD;
             into study. That is to say, patients who completed chemotherapy for more than 2 weeks&#xD;
             can enrolled, or patients has completed chemotherapy for at least one week could be&#xD;
             enrolled at the discretion of the investigator).&#xD;
&#xD;
          5. Patients who have received radio-therapy for bony metastasis, patients receiving&#xD;
             radiotherapy within the 4 week period before study entry (patient receiving&#xD;
             radiotherapy for area other than pain area can be enrolled) , or patients who were&#xD;
             scheduled to receive radiotherapy for pain area during study period.&#xD;
&#xD;
          6. Patients are receiving or should receive anti-convulsion drugs/anti- depression drugs&#xD;
             considered by investigator for the treatment of neuropathy pain. Patients are&#xD;
             receiving or should receive any analgesic other than study medicine, which including&#xD;
             NSAIDs.&#xD;
&#xD;
          7. Patients with other unstable disease, or with dysfunction of important organ.&#xD;
&#xD;
          8. Patients with an ongoing infection, abscess or fever.&#xD;
&#xD;
          9. Patient with serious abnormal liver/ renal function (ALT/Aspartate&#xD;
             Transaminase/creatinine/urea nitrogen) which is higher than 3 times of upper limit;&#xD;
&#xD;
         10. Paralytic or mechanical ileus;&#xD;
&#xD;
         11. Persistent asthma, chronic obstructive diseases, and cor pulmonary;&#xD;
&#xD;
         12. Intracranial neoplasms, and intracranial hypertension with central respiratory&#xD;
             depression risk.&#xD;
&#xD;
         13. Monoamine oxidase inhibitors (MAOIs) or same type drugs have been administered in last&#xD;
             2 weeks;&#xD;
&#xD;
         14. Patients who are currently taking active treatment for epilepsy or arrhythmias.&#xD;
&#xD;
         15. Patients with known sensitivity or record of specific or allergic reaction to&#xD;
             oxycodone or morphine.&#xD;
&#xD;
         16. Patients excluded by the contra-indications, adverse drug reaction (ADRs) and drug&#xD;
             interactions of oxycodone or morphine as detailed in the data sheet, summary of&#xD;
             product characteristics or investigator's brochure.&#xD;
&#xD;
         17. Patients with a history of drug or alcohol abuse.&#xD;
&#xD;
         18. Patients who participated in another clinical research study involving a new chemical&#xD;
             entity within one month prior to study entry.&#xD;
&#xD;
         19. Patients whose concomitant medication is likely to be changed within the study period,&#xD;
             with the exception of treatment for opioid side effects.&#xD;
&#xD;
         20. Patients who, in the opinion of the investigator, are unsuitable to participate in the&#xD;
             study for any other reason not mentioned in the inclusion and exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiying Yu, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan TongJi Hospital</affiliation>
  </overall_official>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>April 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>November 17, 2017</results_first_submitted>
  <results_first_submitted_qc>April 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 21, 2018</results_first_posted>
  <last_update_submitted>April 19, 2018</last_update_submitted>
  <last_update_submitted_qc>April 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cancer Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 242 subjects were enrolled from 20 centers in which 192 subjects completed the study and 50 subjects did not completed the study. All the subjects were recruited from medical clinic.The recruitment period is from 2011 Jan to 2012 Mar.</recruitment_details>
      <pre_assignment_details>Patients with moderate to severe cancer pain requiring oral opioid therapy were screened. All the patients who meets the inclusion/exclusion criteria were enrolled to double blind treatment phase. No wash our or run-in period required by protocol.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Oxycodone Capsules for Cancer Pain</title>
          <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2.&#xD;
period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.</description>
        </group>
        <group group_id="P2">
          <title>Morphine Tablets for Cancer Pain</title>
          <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2.&#xD;
period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oxycodone Capsules for Cancer Pain</title>
          <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
        </group>
        <group group_id="B2">
          <title>Morphine Tablets for Cancer Pain</title>
          <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="120"/>
            <count group_id="B2" value="118"/>
            <count group_id="B3" value="238"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.62" spread="12.96"/>
                    <measurement group_id="B2" value="57.05" spread="12.07"/>
                    <measurement group_id="B3" value="56.83" spread="12.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="236"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>height</title>
          <units>centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="164.5" spread="7.45"/>
                    <measurement group_id="B2" value="164.99" spread="8.20"/>
                    <measurement group_id="B3" value="164.74" spread="7.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.64" spread="10.79"/>
                    <measurement group_id="B2" value="58.34" spread="11.01"/>
                    <measurement group_id="B3" value="58.49" spread="10.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Numerical Rating Scale (NRS)</title>
        <description>The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.</description>
        <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Numerical Rating Scale (NRS)</title>
          <description>The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="2.31"/>
                    <measurement group_id="O2" value="3.87" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Average Dose of Study Medicine Used During Double Blind Treatment Period</title>
        <description>the average dose of study medicine used during double blind treatment period between the two treatment groups.</description>
        <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
        <population>The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>The Average Dose of Study Medicine Used During Double Blind Treatment Period</title>
          <description>the average dose of study medicine used during double blind treatment period between the two treatment groups.</description>
          <population>The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average total dosage during double-blind titration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.29" spread="82.87"/>
                    <measurement group_id="O2" value="141.61" spread="112.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ave. total dosage during double-blind maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167.41" spread="103.92"/>
                    <measurement group_id="O2" value="308.63" spread="189.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period</title>
        <description>The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.</description>
        <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period</title>
          <description>The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Highest pain intensity in 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.25" spread="1.98"/>
                    <measurement group_id="O2" value="4.03" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lowest pain intensity in 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.62" spread="2.08"/>
                    <measurement group_id="O2" value="2.53" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average pain intensity in 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.39" spread="1.80"/>
                    <measurement group_id="O2" value="3.35" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current Pain intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.78" spread="1.94"/>
                    <measurement group_id="O2" value="3.70" spread="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Times of Breakthrough Pain Occurrence</title>
        <description>the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups</description>
        <time_frame>Within 8 days after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Times of Breakthrough Pain Occurrence</title>
          <description>the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups</description>
          <units>breakthrough pain events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Assessments of Satisfaction for Pain Management</title>
        <description>the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.</description>
        <time_frame>baseline up to 19-22 days (open label treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Assessments of Satisfaction for Pain Management</title>
          <description>the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Number of Titrations</title>
        <description>the average times to change the dose in order to find the proper dose between two treatment groups</description>
        <time_frame>baseline up to 1-3 days(double blind period)</time_frame>
        <population>Dosing change frequency for complete titration</population>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Titrations</title>
          <description>the average times to change the dose in order to find the proper dose between two treatment groups</description>
          <population>Dosing change frequency for complete titration</population>
          <units>dose changes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.25" spread="4.52"/>
                    <measurement group_id="O2" value="7.89" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment</title>
        <description>The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.</description>
        <time_frame>baseline up to 19-22 days (open label treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment</title>
          <description>The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Highest pain intensity in 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.98" spread="2.09"/>
                    <measurement group_id="O2" value="3.95" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lowest pain intensity in 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.57" spread="2.05"/>
                    <measurement group_id="O2" value="2.64" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average pain intensity in 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="1.83"/>
                    <measurement group_id="O2" value="3.48" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current Pain intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.62" spread="1.87"/>
                    <measurement group_id="O2" value="3.71" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Total Dose of Rescue Medicine for Breakthrough Pain.</title>
        <description>the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups</description>
        <time_frame>baseline up to 22 days (double blind period)</time_frame>
        <population>The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>the Total Dose of Rescue Medicine for Breakthrough Pain.</title>
          <description>the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups</description>
          <population>The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>the total dose of rescue medicine -day1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.63" spread="7.76"/>
                    <measurement group_id="O2" value="7.00" spread="4.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>the total dose of rescue medicine -day2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.00" spread="8.29"/>
                    <measurement group_id="O2" value="6.00" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>the total dose of rescue medicine-day3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.63" spread="8.21"/>
                    <measurement group_id="O2" value="6.82" spread="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>the total dose of rescue medicine-day4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.00" spread="8.94"/>
                    <measurement group_id="O2" value="7.86" spread="3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>the total dose of rescue medicine-day5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.00" spread="10.84"/>
                    <measurement group_id="O2" value="6.67" spread="4.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>the total dose of rescue medicine -day6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="5.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>the total dose of rescue medicine after day6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" spread="0"/>
                    <measurement group_id="O2" value="5.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Degree of Pain Relief Within 24hrs After Treatment</title>
        <description>Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).</description>
        <time_frame>baseline up to 5-8 days (double blind period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Degree of Pain Relief Within 24hrs After Treatment</title>
          <description>Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).</description>
          <units>percentage of pain relief</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.23" spread="28.27"/>
                    <measurement group_id="O2" value="34.19" spread="30.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment</title>
        <description>For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).</description>
        <time_frame>baseline up to 19-22 days (open label treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone Capsules for Cancer Pain</title>
            <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablets for Cancer Pain</title>
            <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment</title>
          <description>For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).</description>
          <units>percentage of pain relief</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.31" spread="30.80"/>
                    <measurement group_id="O2" value="31.64" spread="29.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 36 days</time_frame>
      <desc>The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oxycodone Capsules for Cancer Pain</title>
          <description>Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days</description>
        </group>
        <group group_id="E2">
          <title>Morphine Tablets for Cancer Pain</title>
          <description>Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ileus</sub_title>
                <description>1 patient had ileus, which was possibly related to the study drug determined by the investigator, and the associated symptoms completely disappeared at the end of follow-up period.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain metastases</sub_title>
                <description>1 patient was hospitalized for brain metastases, which was unrelated to the study drug determined by the investigator, and the associated symptoms still persisted at the end of follow-up period;</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory and circulatory failure</sub_title>
                <description>4 patients died of respiratory/circulatory failure due to progression of the underlying disease, which were not related to the study drug determined by the investigator</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Low platelet count</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="41" subjects_affected="38" subjects_at_risk="120"/>
                <counts group_id="E2" events="47" subjects_affected="43" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="31" subjects_affected="25" subjects_at_risk="120"/>
                <counts group_id="E2" events="30" subjects_affected="26" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="120"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="120"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="120"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="120"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="120"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Loss of appetite</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="120"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="120"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="120"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Pulmonary infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of R&amp;D</name_or_title>
      <organization>Mundipharma (China) phamaceutical CO. LTD</organization>
      <phone>0086-10-65636800</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT01675622
org study id: OXYC10-CN-303
nct id: NCT01675622
lead sponsor: 
has dmc: Yes
The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus
      morphine immediate-release tablets in the treatment of cancer pain.
To compare the efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules
      versus morphine immediate-release tablets in the treatment of cancer pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Numerical Rating Scale (NRS)
time frame: baseline up to 5-8 days (double blind period)
description: The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.
measure: The Average Dose of Study Medicine Used During Double Blind Treatment Period
time frame: baseline up to 5-8 days (double blind period)
description: the average dose of study medicine used during double blind treatment period between the two treatment groups.
measure: Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
time frame: baseline up to 5-8 days (double blind period)
description: The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
measure: Times of Breakthrough Pain Occurrence
time frame: Within 8 days after baseline
description: the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups
measure: Patient Assessments of Satisfaction for Pain Management
time frame: baseline up to 19-22 days (open label treatment)
description: the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.
measure: Average Number of Titrations
time frame: baseline up to 1-3 days(double blind period)
description: the average times to change the dose in order to find the proper dose between two treatment groups
measure: Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
time frame: baseline up to 19-22 days (open label treatment)
description: The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
measure: the Total Dose of Rescue Medicine for Breakthrough Pain.
time frame: baseline up to 22 days (double blind period)
description: the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups
measure: Degree of Pain Relief Within 24hrs After Treatment
time frame: baseline up to 5-8 days (double blind period)
description: Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
measure: Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
time frame: baseline up to 19-22 days (open label treatment)
description: For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
arm group label: Oxycodone Capsules for cancer pain
arm group type: Experimental
arm group label: Morphine tablets for cancer pain
arm group type: Active Comparator
intervention type: Drug
intervention name: Oxycodone
description: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
arm group label: Oxycodone Capsules for cancer pain
other name: No other name in this study
intervention type: Drug
intervention name: Morphine
description: Morphine tablets 10mg and 20mg, oral every 4-6 hours
arm group label: Morphine tablets for cancer pain
other name: No other name
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shiying Yu, Prof.
role: Principal Investigator
affiliation: Wuhan TongJi Hospital
responsible party type: Sponsor
mesh term: Cancer Pain
mesh term: Morphine
mesh term: Oxycodone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 