<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/NCT01685684</url>
  </required_header>
  <id_info>
    <org_study_id>CP-OXYDET-08</org_study_id>
    <nct_id>NCT01685684</nct_id>
  </id_info>
  <brief_title>Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)</brief_title>
  <official_title>A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Collegium Pharmaceutical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Collegium Pharmaceutical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared&#xD;
      with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic&#xD;
      low back pain requiring around-the-clock opioid analgesia for an extended period of time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase</measure>
    <time_frame>Randomized Baseline through Week 12</time_frame>
    <description>The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-to-exit From the Study for All Causes</measure>
    <time_frame>Randomization Baseline through Week 12</time_frame>
    <description>Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Reduction in Pain Intensity for Responders</measure>
    <time_frame>Screening Baseline through Week 12</time_frame>
    <description>Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly Changes in Pain Intensity</measure>
    <time_frame>Randomization Baseline and weekly through Week 12</time_frame>
    <description>Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue Medication Usage by Dose</measure>
    <time_frame>Randomization Baseline through Week 12</time_frame>
    <description>Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue Medication Use by Dosage</measure>
    <time_frame>Randomization Baseline through Week 12</time_frame>
    <description>Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Screening Baseline through Week 12</time_frame>
    <description>The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes &quot;very much improved&quot;, &quot;improved&quot;, &quot;a little improved&quot;, &quot;no change&quot;, &quot;a little worse&quot;, &quot;worse&quot;, and &quot;very much worse&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life</measure>
    <time_frame>Randomization Baseline through Week 12</time_frame>
    <description>Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>Randomization Baseline and Week 12</time_frame>
    <description>The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">740</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Oxycodone DETERx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone DETERx</intervention_name>
    <description>40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h</description>
    <arm_group_label>Oxycodone DETERx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, divided into 2 doses, q12h</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent.&#xD;
&#xD;
          -  Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months&#xD;
             prior to screening.&#xD;
&#xD;
          -  Must qualify for ATC opioid therapy for treatment of CLBP.&#xD;
&#xD;
          -  Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic&#xD;
             (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9)&#xD;
             based on the Quebec Task Force Scale score.&#xD;
&#xD;
          -  Female subjects of childbearing potential will use an acceptable method of birth&#xD;
             control.&#xD;
&#xD;
          -  Must be in general good health based on screening physical examination.&#xD;
&#xD;
          -  Must be willing and able to comply with all study procedures and visit requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known to be refractory or intolerant to the analgesic effects of opioids or have&#xD;
             failed previous opioid therapy.&#xD;
&#xD;
          -  A medical condition that would compromise the subject's ability to swallow, absorb,&#xD;
             metabolize, or excrete the study drug, including (but not limited to) intractable&#xD;
             nausea and/or vomiting and/or severe gastrointestinal narrowing (pathologic or&#xD;
             iatrogenic), bowel obstruction, ileostomy, colostomy, or is suspected of having&#xD;
             paralytic ileus.&#xD;
&#xD;
          -  A surgical procedure for back pain within 6 months prior to the Screening Visit.&#xD;
&#xD;
          -  Any other chronic pain condition other than CLBP that would interfere with the&#xD;
             assessment of CLBP (e.g., osteoarthritis, rheumatoid arthritis, post-herpetic&#xD;
             neuralgia, pain associated with diabetic neuropathy, fibromyalgia, migraine headaches&#xD;
             requiring opioid therapy).&#xD;
&#xD;
          -  Known history of major depressive disorder that is not controlled with medication or&#xD;
             has other conditions that produce significant cognitive or emotional disability.&#xD;
&#xD;
          -  Any clinically significant unstable medical abnormality or acute or chronic disease of&#xD;
             the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary&#xD;
             disease), hepatic, or renal systems.&#xD;
&#xD;
          -  Known history of alcohol and/or drug abuse.&#xD;
&#xD;
          -  Positive urine drug screen for illegal or non-prescribed drugs&#xD;
&#xD;
          -  Known history of seizure disorder, epilepsy, convulsions, or increased intracranial&#xD;
             pressure anytime during the subject's life except pediatric febrile seizures.&#xD;
&#xD;
          -  Known history of head injury within 6 months of Screening Visit.&#xD;
&#xD;
          -  Current malignancy or a history within past 2 years of malignancy, with the exception&#xD;
             of basal cell carcinoma or cervical carcinoma in situ that have been successfully&#xD;
             treated.&#xD;
&#xD;
          -  Positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or&#xD;
             hepatitis C antibody&#xD;
&#xD;
          -  Subject is not able or is unwilling to meet the study attendance requirements.&#xD;
&#xD;
        Other protocol specific inclusion and exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Malamut, MD</last_name>
    <role>Study Director</role>
    <affiliation>Collegium Pharmaceutical, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85282</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Napa</city>
        <state>California</state>
        <zip>94558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32860</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33317</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <zip>46383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Natick</city>
        <state>Massachusetts</state>
        <zip>01760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pascagoula</city>
        <state>Mississippi</state>
        <zip>39581</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Tazewell</city>
        <state>Tennessee</state>
        <zip>37825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Katz N, Kopecky EA, O'Connor M, Brown RH, Fleming AB. A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. Pain. 2015 Dec;156(12):2458-2467. doi: 10.1097/j.pain.0000000000000315.</citation>
    <PMID>26262828</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>May 25, 2016</results_first_submitted>
  <results_first_submitted_qc>January 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2017</results_first_posted>
  <disposition_first_submitted>May 22, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 22, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 19, 2015</disposition_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Chronic back pain</keyword>
  <keyword>Back pain</keyword>
  <keyword>Opioid</keyword>
  <keyword>Oxycodone</keyword>
  <keyword>DETERx</keyword>
  <keyword>Chronic pain</keyword>
  <keyword>Chronic low back pain</keyword>
  <keyword>CLBP</keyword>
  <keyword>Xtampza</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The titration (i.e., enrichment) phase of the study was designed to titrate patients to a dose of Oxycodone DETERx that balanced pain control and tolerability to ensure that only patients who experienced a substantial reduction from the screening pain assessment and who can tolerate side effects continue into the Double-blind Maintenance Phase.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Oxycodone DETERx (Titration Phase)</title>
          <description>Achieve a stable Oxycodone DETERx dose of 40-160 mg total daily dose.</description>
        </group>
        <group group_id="P2">
          <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          <description>Oxycodone DETERx: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h</description>
        </group>
        <group group_id="P3">
          <title>Placebo (Double-blind Maintenance Phase)</title>
          <description>Placebo: Placebo, divided into 2 doses, q12h</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Titration Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="740"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="389"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="351"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Double-blind Maintenance Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="193"/>
                <participants group_id="P3" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="122"/>
                <participants group_id="P3" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="96"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
        </group>
        <group group_id="B2">
          <title>Placebo (Double-blind Maintenance Phase)</title>
        </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="193"/>
            <count group_id="B2" value="196"/>
            <count group_id="B3" value="389"/>
          </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="49.2" spread="13.31"/>
                    <measurement group_id="B2" value="49.9" spread="12.56"/>
                    <measurement group_id="B3" value="49.5" spread="12.93"/>
                  </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="103"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain Intensity-Numeric Rating Scale (PI-NRS)</title>
          <description>The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" spread="1.04"/>
                    <measurement group_id="B2" value="2.9" spread="0.97"/>
                    <measurement group_id="B3" value="2.9" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase</title>
        <description>The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).</description>
        <time_frame>Randomized Baseline through Week 12</time_frame>
        <population>One subject is missing all Average Weekly Pain Scores after Screening in the Oxycodone DETERx treatment group. This subject has been excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase</title>
          <description>The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).</description>
          <population>One subject is missing all Average Weekly Pain Scores after Screening in the Oxycodone DETERx treatment group. This subject has been excluded from the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.146"/>
                    <measurement group_id="O2" value="1.85" spread="0.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>z-test</method>
            <param_type>Marginal Mean Difference (Net)</param_type>
            <param_value>-1.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.267</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time-to-exit From the Study for All Causes</title>
        <description>Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.</description>
        <time_frame>Randomization Baseline through Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Time-to-exit From the Study for All Causes</title>
          <description>Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.</description>
          <units>Days</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.0" lower_limit="37.0" upper_limit="78.0"/>
                    <measurement group_id="O2" value="35.0" lower_limit="29.0" upper_limit="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Reduction in Pain Intensity for Responders</title>
        <description>Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.</description>
        <time_frame>Screening Baseline through Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Percent Reduction in Pain Intensity for Responders</title>
          <description>Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with 30% Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with 50% Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weekly Changes in Pain Intensity</title>
        <description>Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).</description>
        <time_frame>Randomization Baseline and weekly through Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Weekly Changes in Pain Intensity</title>
          <description>Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).</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="193"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.85"/>
                    <measurement group_id="O2" value="0.3" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="1.05"/>
                    <measurement group_id="O2" value="0.4" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.14"/>
                    <measurement group_id="O2" value="0.5" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.25"/>
                    <measurement group_id="O2" value="0.8" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.41"/>
                    <measurement group_id="O2" value="0.7" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.45"/>
                    <measurement group_id="O2" value="0.7" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.35"/>
                    <measurement group_id="O2" value="0.7" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="1.29"/>
                    <measurement group_id="O2" value="0.8" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.59"/>
                    <measurement group_id="O2" value="0.7" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.55"/>
                    <measurement group_id="O2" value="0.7" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.62"/>
                    <measurement group_id="O2" value="0.8" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.54"/>
                    <measurement group_id="O2" value="0.8" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rescue Medication Usage by Dose</title>
        <description>Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)</description>
        <time_frame>Randomization Baseline through Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Rescue Medication Usage by Dose</title>
          <description>Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)</description>
          <units>doses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Doses per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.297"/>
                    <measurement group_id="O2" value="0.23" spread="0.458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doses per Week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="2.081"/>
                    <measurement group_id="O2" value="1.60" spread="3.206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Number of Doses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="16.38"/>
                    <measurement group_id="O2" value="11.2" spread="31.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rescue Medication Use by Dosage</title>
        <description>Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)</description>
        <time_frame>Randomization Baseline through Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Rescue Medication Use by Dosage</title>
          <description>Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)</description>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosage per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.63" spread="289.472"/>
                    <measurement group_id="O2" value="189.32" spread="317.605"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dosage per Week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1012.39" spread="2026.298"/>
                    <measurement group_id="O2" value="1325.27" spread="2223.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Dosage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7873.1" spread="16665.70"/>
                    <measurement group_id="O2" value="9028.1" spread="20441.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGIC)</title>
        <description>The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes &quot;very much improved&quot;, &quot;improved&quot;, &quot;a little improved&quot;, &quot;no change&quot;, &quot;a little worse&quot;, &quot;worse&quot;, and &quot;very much worse&quot;.</description>
        <time_frame>Screening Baseline through Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGIC)</title>
          <description>The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes &quot;very much improved&quot;, &quot;improved&quot;, &quot;a little improved&quot;, &quot;no change&quot;, &quot;a little worse&quot;, &quot;worse&quot;, and &quot;very much worse&quot;.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A Little Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A Little Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Much Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Quality of Life</title>
        <description>Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.</description>
        <time_frame>Randomization Baseline through Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Changes in Quality of Life</title>
          <description>Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Component Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.524" spread="10.1327"/>
                    <measurement group_id="O2" value="3.622" spread="9.4290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.554" spread="10.4145"/>
                    <measurement group_id="O2" value="0.674" spread="11.1676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.35"/>
                    <measurement group_id="O2" value="0.5" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="2.35"/>
                    <measurement group_id="O2" value="0.6" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.16"/>
                    <measurement group_id="O2" value="0.4" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.784"/>
                    <measurement group_id="O2" value="0.22" spread="0.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)</title>
        <description>The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.</description>
        <time_frame>Randomization Baseline and Week 12</time_frame>
        <population>The RMDQ was analyzed and presented as a change from Randomization Baseline to Week 12. Subjects' scores from Early Discontinuation visits were not included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
          </group>
          <group group_id="O2">
            <title>Placebo (Double-blind Maintenance Phase)</title>
          </group>
        </group_list>
        <measure>
          <title>Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)</title>
          <description>The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.</description>
          <population>The RMDQ was analyzed and presented as a change from Randomization Baseline to Week 12. Subjects' scores from Early Discontinuation visits were not included in this 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="109"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="4.83"/>
                    <measurement group_id="O2" value="0.7" spread="5.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected from the time of first dose with study drug to the End-of-Study Visit/Early Discontinuation Visit. All AEs that were ongoing at the subject's last study visit were to be followed until resolution or for 30 days after the subject's last study drug dose, whichever came first.</time_frame>
      <desc>Serious adverse events (SAEs) were collected from informed consent until 30 days post last dose. If the Investigator became aware of an SAE within 30 days after the subject's last study drug dose, or through the last study visit, the SAE was to be reported. All SAEs, including those ongoing at End-of-Study/Early Discontinuation, were followed until resolution or until the outcome became chronically stable, or if no additional information could be obtained after unsuccessful contact attempts.</desc>
      <group_list>
        <group group_id="E1">
          <title>Screening</title>
          <description>Serious Adverse Event (SAE) collection started during screening.</description>
        </group>
        <group group_id="E2">
          <title>Oxycodone DETERx (Titration Phase)</title>
        </group>
        <group group_id="E3">
          <title>Oxycodone DETERx (Double-blind Maintenance Phase)</title>
        </group>
        <group group_id="E4">
          <title>Placebo (Double-blind Maintenance Phase)</title>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <description>Not related to study drug as assessed by Principal Investigator and Medical Monitor</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Pituitary tumour benign</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Benign hydatidiform mole</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1297"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="531" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="60" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="39" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Non-serious Adverse Events were not collected during screening.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="123" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Non-serious Adverse Events were not collected during screening.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="96" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Non-serious Adverse Events were not collected during screening.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Non-serious Adverse Events were not collected during screening.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="103" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <description>Non-serious Adverse Events were not collected during screening.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <description>Non-serious Adverse Events were not collected during screening.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <description>Non-serious Adverse Events were not collected during screening.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="740"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="193"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="196"/>
              </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>If a joint manuscript has not been submitted for publication within twelve (12) months of completion or termination of the study, the PI is free to publish separately, upon provision of any proposed publication or manuscript to the Sponsor at least sixty (60) days before it is submitted or otherwise disclosed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Scientist</name_or_title>
      <organization>Collegium Pharmaceutical</organization>
      <phone>+1.781.232.0764</phone>
      <email>clinicaltrials@collegiumpharma.com</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/NCT01685684
org study id: CP-OXYDET-08
nct id: NCT01685684
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared
      with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic
      low back pain requiring around-the-clock opioid analgesia for an extended period of time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase
time frame: Randomized Baseline through Week 12
description: The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
measure: Time-to-exit From the Study for All Causes
time frame: Randomization Baseline through Week 12
description: Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.
measure: Percent Reduction in Pain Intensity for Responders
time frame: Screening Baseline through Week 12
description: Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.
measure: Weekly Changes in Pain Intensity
time frame: Randomization Baseline and weekly through Week 12
description: Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).
measure: Rescue Medication Usage by Dose
time frame: Randomization Baseline through Week 12
description: Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)
measure: Rescue Medication Use by Dosage
time frame: Randomization Baseline through Week 12
description: Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)
measure: Patient Global Impression of Change (PGIC)
time frame: Screening Baseline through Week 12
description: The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes "very much improved", "improved", "a little improved", "no change", "a little worse", "worse", and "very much worse".
measure: Changes in Quality of Life
time frame: Randomization Baseline through Week 12
description: Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.
measure: Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)
time frame: Randomization Baseline and Week 12
description: The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.
arm group label: Oxycodone DETERx
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Oxycodone DETERx
description: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
arm group label: Oxycodone DETERx
intervention type: Drug
intervention name: Placebo
description: Placebo, divided into 2 doses, q12h
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Richard Malamut, MD
role: Study Director
affiliation: Collegium Pharmaceutical, Inc.
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country: United States
citation: Katz N, Kopecky EA, O'Connor M, Brown RH, Fleming AB. A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. Pain. 2015 Dec;156(12):2458-2467. doi: 10.1097/j.pain.0000000000000315.
PMID: 26262828
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Oxycodone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 