<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/NCT01675635</url>
  </required_header>
  <id_info>
    <org_study_id>OXYC11-CN-304</org_study_id>
    <nct_id>NCT01675635</nct_id>
  </id_info>
  <brief_title>OxyNorm Capsules in Post-Operative Pain Study</brief_title>
  <official_title>A Double-blind, Randomized, Parallel Group Study to Compare the Efficacy and Safety, of Oxycodone Immediate-release Capsules Versus Morphine Immediate-release Tablets in Hospitalized Patients With Moderate to Severe Pain Following Surgery.</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 and safety of oxycodone capsules compared with morphine tablets in hospitalized&#xD;
      patients with moderate to severe pain following surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with&#xD;
      morphine immediate-release tablets in hospitalized patients with moderate to severe pain&#xD;
      following surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)</measure>
    <time_frame>Baseline and 6h (±20min)</time_frame>
    <description>To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison&#xD;
Visual Analogue Scale&#xD;
0 10 20 30 40 50 60 70 80 90 100&#xD;
0 means no pain; 100 means pain as bad as you can image at resting stage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose</measure>
    <time_frame>Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)</time_frame>
    <description>To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Use of Rescue Analgesics During the 24-hour Observation Period</measure>
    <time_frame>24 hours after the first dose.</time_frame>
    <description>To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)</measure>
    <time_frame>Baseline and 6h (±20min)</time_frame>
    <description>To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison&#xD;
Visual Analogue Scale&#xD;
0 10 20 30 40 50 60 70 80 90 100&#xD;
0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleeping Quality Assessment</measure>
    <time_frame>24 hours after administration of first dose</time_frame>
    <description>To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison&#xD;
Sleeping quality scale&#xD;
Very Good&#xD;
Good&#xD;
Fair&#xD;
Bad&#xD;
Very Bad</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Pain Control</measure>
    <time_frame>24 hours after administration of first dose</time_frame>
    <description>To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Fair&#xD;
Not Satisfied&#xD;
Not Satisfied at all</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the Total Amount of Study Drugs Used During the 24 Hours</measure>
    <time_frame>24 hours after administration of first dose</time_frame>
    <description>To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison&#xD;
The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>OxyNorm Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To determine the efficacy and safety of OxyNorm Capsules.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To determine the efficacy and safety of Morphine tablet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OxyNorm Capsules</intervention_name>
    <description>dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
    <arm_group_label>OxyNorm Capsules</arm_group_label>
    <other_name>OxyNorm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Morphine tablet</intervention_name>
    <description>dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
    <arm_group_label>Morphine tablet</arm_group_label>
    <other_name>Morphine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of either sex aged 18 to 80 years inclusive.&#xD;
&#xD;
          2. Patients who have given written informed consent to participate in the study.&#xD;
&#xD;
          3. Able and willing to communicate with the investigator and his/her staff.&#xD;
&#xD;
          4. Free of anesthesia as assessed through question and answer interaction with nurse at&#xD;
             which time oral medication is indicated.&#xD;
&#xD;
          5. Reporting &quot;moderate&quot; or &quot;severe&quot; pain (VAS ≥ 4) related to surgery and requesting&#xD;
             analgesics for pain relief.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients have developed tolerance to or dependence on narcotic analgesics and/or&#xD;
             alcohol.&#xD;
&#xD;
          2. Patients with ASA ≥ 3 .&#xD;
&#xD;
          3. Have any concomitant medical condition that would be adversely affected by analgesics&#xD;
             or confound the quantification of analgesia, or could affect the absorption,&#xD;
             metabolism or excretion of the study drugs in any clinically significant fashion.&#xD;
&#xD;
          4. Have known hypersensitivity to any of the study medications or related agents.&#xD;
&#xD;
          5. Have taken analgesic medications within three hours (wash-out) prior to dosing.&#xD;
&#xD;
          6. Have developed complications from the surgical procedure that would confound the&#xD;
             study.&#xD;
&#xD;
          7. Have a history of severe iatrogenic adverse experiences.&#xD;
&#xD;
          8. Mothers nursing their infant during the 24 hours following study drug administration,&#xD;
             or pregnant women.&#xD;
&#xD;
          9. Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.&#xD;
&#xD;
         10. Surgery in patients with epidural anesthesia&#xD;
&#xD;
         11. Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times&#xD;
             upper limit) and abnormal renal function.&#xD;
&#xD;
         12. Patients with medical history of recovering from abnormal surgery anesthesia.&#xD;
&#xD;
         13. Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg,&#xD;
             Diastolic blood pressure 110Hg).&#xD;
&#xD;
         14. Patients with shock.&#xD;
&#xD;
         15. Patients with COPD.&#xD;
&#xD;
         16. According to investigator to determine, patients are in addition the inclusion&#xD;
             criteria and exclusion criteria for any other reason than not suitable in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>XinMin Wu, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University 1st Hospital</affiliation>
  </overall_official>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>April 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>November 21, 2017</results_first_submitted>
  <results_first_submitted_qc>February 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 26, 2018</results_first_posted>
  <last_update_submitted>February 23, 2018</last_update_submitted>
  <last_update_submitted_qc>February 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study is a randomized, double blind, double dummy, multicenter, parallel group, comparative study to compare the efficacy and safety of oxycodone capsule versus morphine tablet. The subject recruited from hospitalized patients poor with moderate to severe pain following surgery. The duration of the study from 2011 Jul to 2011 Dec.</recruitment_details>
      <pre_assignment_details>There is no run-in or wash out period involved in this study.&#xD;
On the protocol 240 subjects was planned to be enrolled, but actually 234 subjects was screened and all randomized. Zero screen failure is reasonable for the indication with this study design.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>OxyNorm Capsules</title>
          <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
        </group>
        <group group_id="P2">
          <title>Morphine Tablet</title>
          <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OxyNorm Capsules</title>
          <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
        </group>
        <group group_id="B2">
          <title>Morphine Tablet</title>
          <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 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="117"/>
            <count group_id="B2" value="117"/>
            <count group_id="B3" value="234"/>
          </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="43.44" spread="11.06"/>
                    <measurement group_id="B2" value="43.29" spread="10.53"/>
                    <measurement group_id="B3" value="43.37" spread="10.77"/>
                  </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="101"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="40"/>
                  </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="116"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="233"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="117"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Electrocardiogram test</title>
          <description>the judgement of result normal, abnormal non clinical significant or abnormal clinical significant was made by the doctor according to the clinical practice. the study protocol does not have additional or particular requirement.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>abnormal, not clinical significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>abnormal,clinical significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>America Society of Anesthesiologist classification</title>
          <description>ASA Physical Status Classification System&#xD;
P1 A normal healthy patient P2 A patient with mild systemic disease P3 A patient with severe systemic disease P4 A patient with severe systemic disease that is a constant threat to life P5 A moribund patient who is not expected to survive without the operation P6 A declared brain-dead patient whose organ are being removed for donor purposes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>P1(Class I)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P2(Class II)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)</title>
        <description>To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison&#xD;
Visual Analogue Scale&#xD;
0 10 20 30 40 50 60 70 80 90 100&#xD;
0 means no pain; 100 means pain as bad as you can image at resting stage</description>
        <time_frame>Baseline and 6h (±20min)</time_frame>
        <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>OxyNorm Capsules</title>
            <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablet</title>
            <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)</title>
          <description>To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison&#xD;
Visual Analogue Scale&#xD;
0 10 20 30 40 50 60 70 80 90 100&#xD;
0 means no pain; 100 means pain as bad as you can image at resting stage</description>
          <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
          <units>units 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="113"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline of Visual Analogue Scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.21" spread="9.53"/>
                    <measurement group_id="O2" value="45.48" spread="7.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6th hours Visual Analogue Scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.21" spread="15.66"/>
                    <measurement group_id="O2" value="19.94" spread="15.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose</title>
        <description>To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison</description>
        <time_frame>Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OxyNorm Capsules</title>
            <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablet</title>
            <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose</title>
          <description>To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison</description>
          <units>units 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="113"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Resting baseline of Visual Analogue Scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.21" spread="9.53"/>
                    <measurement group_id="O2" value="45.48" spread="7.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Resting visual analogue scale before first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.21" spread="9.53"/>
                    <measurement group_id="O2" value="45.48" spread="7.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Resting VAS 0.5 hour after first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.87" spread="13.59"/>
                    <measurement group_id="O2" value="29.80" spread="12.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Resting VAS 2 hours after first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.58" spread="14.40"/>
                    <measurement group_id="O2" value="20.89" spread="12.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Resting VAS 24 hours after first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.73" spread="12.52"/>
                    <measurement group_id="O2" value="9.75" spread="11.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coughing baseline of Visual Analogue Scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.16" spread="12.15"/>
                    <measurement group_id="O2" value="53.91" spread="10.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coughing visual analogue scale before first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.20" spread="12.12"/>
                    <measurement group_id="O2" value="53.91" spread="10.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coughing VAS 0.5 hour after first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.21" spread="16.56"/>
                    <measurement group_id="O2" value="37.96" spread="13.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coughing VAS 2hours after first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.68" spread="17.91"/>
                    <measurement group_id="O2" value="29.30" spread="13.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coughing VAS 24hours after first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.11" spread="13.51"/>
                    <measurement group_id="O2" value="16.27" spread="12.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Use of Rescue Analgesics During the 24-hour Observation Period</title>
        <description>To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison</description>
        <time_frame>24 hours after the first dose.</time_frame>
        <population>in FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>OxyNorm Capsules</title>
            <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablet</title>
            <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage:20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>The Use of Rescue Analgesics During the 24-hour Observation Period</title>
          <description>To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison</description>
          <population>in FAS population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First dose interval(0-6h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second dose interval(7-12h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Third dose interval(13-18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fourth dose interval(19-24h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)</title>
        <description>To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison&#xD;
Visual Analogue Scale&#xD;
0 10 20 30 40 50 60 70 80 90 100&#xD;
0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage</description>
        <time_frame>Baseline and 6h (±20min)</time_frame>
        <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>OxyNorm Capsules</title>
            <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablet</title>
            <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)</title>
          <description>To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison&#xD;
Visual Analogue Scale&#xD;
0 10 20 30 40 50 60 70 80 90 100&#xD;
0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage</description>
          <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
          <units>units 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="113"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visual Analogue Scale of baseline coughing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.16" spread="12.15"/>
                    <measurement group_id="O2" value="53.91" spread="10.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visual Analogue Scale after 6hours coughing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.81" spread="17.58"/>
                    <measurement group_id="O2" value="28.15" spread="16.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleeping Quality Assessment</title>
        <description>To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison&#xD;
Sleeping quality scale&#xD;
Very Good&#xD;
Good&#xD;
Fair&#xD;
Bad&#xD;
Very Bad</description>
        <time_frame>24 hours after administration of first dose</time_frame>
        <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>OxyNorm Capsules</title>
            <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablet</title>
            <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleeping Quality Assessment</title>
          <description>To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison&#xD;
Sleeping quality scale&#xD;
Very Good&#xD;
Good&#xD;
Fair&#xD;
Bad&#xD;
Very Bad</description>
          <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Bad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Pain Control</title>
        <description>To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Fair&#xD;
Not Satisfied&#xD;
Not Satisfied at all</description>
        <time_frame>24 hours after administration of first dose</time_frame>
        <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>OxyNorm Capsules</title>
            <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablet:</title>
            <description>To determine the efficacy and safety of Morphine tablet.&#xD;
dosage: 20mg dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Pain Control</title>
          <description>To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Fair&#xD;
Not Satisfied&#xD;
Not Satisfied at all</description>
          <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Satisfied at all</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of the Total Amount of Study Drugs Used During the 24 Hours</title>
        <description>To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison&#xD;
The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.</description>
        <time_frame>24 hours after administration of first dose</time_frame>
        <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>OxyNorm Capsules</title>
            <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
          </group>
          <group group_id="O2">
            <title>Morphine Tablet</title>
            <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of the Total Amount of Study Drugs Used During the 24 Hours</title>
          <description>To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison&#xD;
The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.</description>
          <population>234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.</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="113"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.50" spread="10.37"/>
                    <measurement group_id="O2" value="39.82" spread="21.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The protocol requires safety follow up until 24 hours after the last study medication dosing. So the longest time one subject in the study is 48 hours after the 1st study medication doing, include taking full of the 4 times dosing(intotal 24 hours) following by safety follow up for 24 hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>OxyNorm Capsules</title>
          <description>To determine the efficacy and safety of OxyNorm Capsules.&#xD;
OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours</description>
        </group>
        <group group_id="E2">
          <title>Morphine Tablet</title>
          <description>To determine the efficacy and safety of Morphine tablet.&#xD;
Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </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="35" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>serum creatinine increase</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>alanine aminotransferase increase</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>aspartate aminotransferase increase</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>glycosylated hemoglobin derease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>blood glucose increase</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>leucocyte count increase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="117"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="117"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>abdominal distension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>chest uncomfortable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>postoperative infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>backache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>high tension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>muculoskeletalache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>epigastric pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="117"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>blood urea increase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>expectoration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
              </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>Ms. Dan Zhu, Clinical operation and quality lead of the study</name_or_title>
      <organization>Mundipharma (China) pharmaceutical Co, LTD.</organization>
      <phone>0086-10-65636800</phone>
      <email>medical.mcpc@mundipharma.com.cn</email>
    </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/NCT01675635
org study id: OXYC11-CN-304
nct id: NCT01675635
lead sponsor: 
has dmc: Yes
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized
      patients with moderate to severe pain following surgery.
To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with
      morphine immediate-release tablets in hospitalized patients with moderate to severe pain
      following surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)
time frame: Baseline and 6h (±20min)
description: To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison
Visual Analogue Scale
0 10 20 30 40 50 60 70 80 90 100
0 means no pain; 100 means pain as bad as you can image at resting stage
measure: VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose
time frame: Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)
description: To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison
measure: The Use of Rescue Analgesics During the 24-hour Observation Period
time frame: 24 hours after the first dose.
description: To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison
measure: VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)
time frame: Baseline and 6h (±20min)
description: To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison
Visual Analogue Scale
0 10 20 30 40 50 60 70 80 90 100
0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage
measure: Sleeping Quality Assessment
time frame: 24 hours after administration of first dose
description: To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison
Sleeping quality scale
Very Good
Good
Fair
Bad
Very Bad
measure: Satisfaction With Pain Control
time frame: 24 hours after administration of first dose
description: To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison
Very Satisfied
Satisfied
Fair
Not Satisfied
Not Satisfied at all
measure: Comparison of the Total Amount of Study Drugs Used During the 24 Hours
time frame: 24 hours after administration of first dose
description: To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison
The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.
arm group label: OxyNorm Capsules
arm group type: Experimental
description: To determine the efficacy and safety of OxyNorm Capsules.
arm group label: Morphine tablet
arm group type: Active Comparator
description: To determine the efficacy and safety of Morphine tablet.
intervention type: Drug
intervention name: OxyNorm Capsules
description: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours
arm group label: OxyNorm Capsules
other name: OxyNorm
intervention type: Other
intervention name: Morphine tablet
description: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
arm group label: Morphine tablet
other name: Morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: XinMin Wu, Prof.
role: Principal Investigator
affiliation: Peking University 1st Hospital
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Morphine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 