<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/NCT03277066</url>
  </required_header>
  <id_info>
    <org_study_id>HP-5000-US-05</org_study_id>
    <nct_id>NCT03277066</nct_id>
  </id_info>
  <brief_title>A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis</brief_title>
  <acronym>HP-5000</acronym>
  <official_title>A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis (OA) of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noven Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Noven Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate&#xD;
      the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study&#xD;
      evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist&#xD;
      of up to 28-day Screening Phase that will include a Washout Period of current prescription&#xD;
      and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week&#xD;
      safety Follow-up Period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">September 25, 2019</completion_date>
  <primary_completion_date type="Actual">September 25, 2019</primary_completion_date>
  <phase>Phase 2</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>Evaluate Efficacy &amp; Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WOMAC Pain Score Week 2 Change From Baseline</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 2. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Stiffness Score Change From Baseline</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score from baseline to week 4. The WOMAC Stiffness scale assesses 2 items including morning stiffness and stiffness occurring later in the day. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of two items range from 0 to 8 with a low score considered as a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Physical Function Score</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score from baseline to week 4. The WOMAC Physical Function assesses the following 17 items using the 0 to 4 scale. These 17 items include: 1. descending stairs; 2. ascending stairs; 3. rising from sitting; 4. standing; 5. bending to floor; 6. walking on a flat surface; 7. getting in/getting out of car; 8. going shopping; 9. putting on socks; 10. lying in bed; 11. taking off socks; 12. rising from bed; 13. getting in/out of bath; 14. sitting; 15. getting on/off toilet; 16. heavy domestic duties; 17. light domestic duties. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. Total score range from 0 to 68 with lower score considered a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">289</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <arm_group>
    <arm_group_label>Diclofenac Sodium Active Topical Patch 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diclofenac sodium 1 topical patches will be compared against placebo patches.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac Sodium Active Topical Patch 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diclofenac sodium 2 topical patches will be compared against placebo patches.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Sodium Active Topical Patch 1</intervention_name>
    <description>HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s)</description>
    <arm_group_label>Diclofenac Sodium Active Topical Patch 1</arm_group_label>
    <other_name>HP-5000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Sodium Active Topical Patch 2</intervention_name>
    <description>HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s)</description>
    <arm_group_label>Diclofenac Sodium Active Topical Patch 2</arm_group_label>
    <other_name>HP-5000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo patch</intervention_name>
    <description>Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)</description>
    <arm_group_label>Diclofenac Sodium Active Topical Patch 1</arm_group_label>
    <arm_group_label>Diclofenac Sodium Active Topical Patch 2</arm_group_label>
    <other_name>Placebo treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee&#xD;
             according to the American College of Rheumatology (ACR) criteria, including:&#xD;
&#xD;
          -  Symptoms for at least 6 months prior to screening, AND&#xD;
&#xD;
          -  Knee pain in the target knee for 30 days of the preceding month (periarticular knee&#xD;
             pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND&#xD;
&#xD;
          -  The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs&#xD;
             (NSAIDs) either over the counter (OTC) per recommendation of a physician or&#xD;
             prescribed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 40&#xD;
&#xD;
          -  Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue&#xD;
             medication) during Screening Washout Period.&#xD;
&#xD;
          -  Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic&#xD;
             neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunnar Klauss, MD, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Noven Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Noven Pharmaceuticals, Inc.</name>
      <address>
        <city>Jersey City</city>
        <state>New Jersey</state>
        <zip>07310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <results_first_submitted>September 30, 2021</results_first_submitted>
  <results_first_submitted_qc>November 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2021</results_first_posted>
  <last_update_submitted>November 23, 2021</last_update_submitted>
  <last_update_submitted_qc>November 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03277066/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03277066/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Diclofenac Sodium Active Topical Patch 1</title>
          <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
        <group group_id="P2">
          <title>Diclofenac Sodium Active Topical Patch 2</title>
          <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
        <group group_id="P3">
          <title>Placebo Patch</title>
          <description>Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="72"/>
                <participants group_id="P3" count="146"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="143"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HP-5000-75α Patch (5% Diclofenac Sodium)</title>
          <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s for 4-week treatment.</description>
        </group>
        <group group_id="B2">
          <title>HP-5000-DRS400 Patch (5% Diclofenac Sodium)</title>
          <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
        <group group_id="B3">
          <title>Placebo Patch</title>
          <description>Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
        <group group_id="B4">
          <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="69"/>
            <count group_id="B2" value="71"/>
            <count group_id="B3" value="143"/>
            <count group_id="B4" value="283"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.1" spread="8.66"/>
                    <measurement group_id="B2" value="57.1" spread="8.65"/>
                    <measurement group_id="B3" value="59" spread="8.46"/>
                    <measurement group_id="B4" value="57.8" spread="8.62"/>
                  </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="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="107"/>
                    <measurement group_id="B4" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="109"/>
                    <measurement group_id="B4" value="212"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="143"/>
                    <measurement group_id="B4" value="283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.51" spread="5.103"/>
                    <measurement group_id="B2" value="29.83" spread="4.898"/>
                    <measurement group_id="B3" value="29.89" spread="5.257"/>
                    <measurement group_id="B4" value="29.78" spread="5.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluate Efficacy &amp; Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score</title>
        <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.</description>
        <time_frame>Baseline and 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diclofenac Sodium Active Topical Patch 1</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O2">
            <title>Diclofenac Sodium Active Topical Patch 2</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Patch</title>
            <description>Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate Efficacy &amp; Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score</title>
          <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.</description>
          <units>score 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="69"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" spread="4.47"/>
                    <measurement group_id="O2" value="-5.6" spread="4.06"/>
                    <measurement group_id="O3" value="-5.2" spread="4.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0110</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Lest-Squared Mean Differences</param_type>
            <param_value>0.0110</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2835</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Lest-Squared Mean Differences</param_type>
            <param_value>0.2835</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Pain Score Week 2 Change From Baseline</title>
        <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 2. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diclofenac Sodium Active Topical Patch 1</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O2">
            <title>Diclofenac Sodium Active Topical Patch 2</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Patch</title>
            <description>Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Pain Score Week 2 Change From Baseline</title>
          <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 2. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.</description>
          <units>score 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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="4.29"/>
                    <measurement group_id="O2" value="-5.3" spread="3.67"/>
                    <measurement group_id="O3" value="-5.0" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Stiffness Score Change From Baseline</title>
        <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score from baseline to week 4. The WOMAC Stiffness scale assesses 2 items including morning stiffness and stiffness occurring later in the day. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of two items range from 0 to 8 with a low score considered as a better outcome.</description>
        <time_frame>Baseline and 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diclofenac Sodium Active Topical Patch 1</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O2">
            <title>Diclofenac Sodium Active Topical Patch 2</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Patch</title>
            <description>Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Stiffness Score Change From Baseline</title>
          <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score from baseline to week 4. The WOMAC Stiffness scale assesses 2 items including morning stiffness and stiffness occurring later in the day. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of two items range from 0 to 8 with a low score considered as a better outcome.</description>
          <units>score 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="67"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="2.06"/>
                    <measurement group_id="O2" value="-2.1" spread="1.94"/>
                    <measurement group_id="O3" value="-1.7" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Physical Function Score</title>
        <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score from baseline to week 4. The WOMAC Physical Function assesses the following 17 items using the 0 to 4 scale. These 17 items include: 1. descending stairs; 2. ascending stairs; 3. rising from sitting; 4. standing; 5. bending to floor; 6. walking on a flat surface; 7. getting in/getting out of car; 8. going shopping; 9. putting on socks; 10. lying in bed; 11. taking off socks; 12. rising from bed; 13. getting in/out of bath; 14. sitting; 15. getting on/off toilet; 16. heavy domestic duties; 17. light domestic duties. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. Total score range from 0 to 68 with lower score considered a better outcome.</description>
        <time_frame>Baseline and 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diclofenac Sodium Active Topical Patch 1</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O2">
            <title>Diclofenac Sodium Active Topical Patch 2</title>
            <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Patch</title>
            <description>Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Physical Function Score</title>
          <description>To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score from baseline to week 4. The WOMAC Physical Function assesses the following 17 items using the 0 to 4 scale. These 17 items include: 1. descending stairs; 2. ascending stairs; 3. rising from sitting; 4. standing; 5. bending to floor; 6. walking on a flat surface; 7. getting in/getting out of car; 8. going shopping; 9. putting on socks; 10. lying in bed; 11. taking off socks; 12. rising from bed; 13. getting in/out of bath; 14. sitting; 15. getting on/off toilet; 16. heavy domestic duties; 17. light domestic duties. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. Total score range from 0 to 68 with lower score considered a better outcome.</description>
          <units>score 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="69"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.8" spread="14.85"/>
                    <measurement group_id="O2" value="-19.3" spread="13.63"/>
                    <measurement group_id="O3" value="-15.6" spread="13.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Diclofenac Sodium Active Topical Patch 1</title>
          <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
        <group group_id="E2">
          <title>Diclofenac Sodium Active Topical Patch 2</title>
          <description>Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.&#xD;
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
        <group group_id="E3">
          <title>Placebo Patch</title>
          <description>Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="9" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Product taste abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="143"/>
              </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 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>Gunnar Klauss, MD</name_or_title>
      <organization>Noven Pharmaceuticals, Inc.</organization>
      <phone>1-551-233-2656</phone>
      <email>gklauss@noven.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/NCT03277066
org study id: HP-5000-US-05
nct id: NCT03277066
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate
      the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee
This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study
      evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist
      of up to 28-day Screening Phase that will include a Washout Period of current prescription
      and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week
      safety Follow-up Period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score
time frame: Baseline and 4 weeks
description: To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.
measure: WOMAC Pain Score Week 2 Change From Baseline
time frame: Baseline and 2 weeks
description: To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 2. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.
measure: WOMAC Stiffness Score Change From Baseline
time frame: Baseline and 4 weeks
description: To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score from baseline to week 4. The WOMAC Stiffness scale assesses 2 items including morning stiffness and stiffness occurring later in the day. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of two items range from 0 to 8 with a low score considered as a better outcome.
measure: WOMAC Physical Function Score
time frame: Baseline and 4 weeks
description: To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score from baseline to week 4. The WOMAC Physical Function assesses the following 17 items using the 0 to 4 scale. These 17 items include: 1. descending stairs; 2. ascending stairs; 3. rising from sitting; 4. standing; 5. bending to floor; 6. walking on a flat surface; 7. getting in/getting out of car; 8. going shopping; 9. putting on socks; 10. lying in bed; 11. taking off socks; 12. rising from bed; 13. getting in/out of bath; 14. sitting; 15. getting on/off toilet; 16. heavy domestic duties; 17. light domestic duties. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. Total score range from 0 to 68 with lower score considered a better outcome.
arm group label: Diclofenac Sodium Active Topical Patch 1
arm group type: Experimental
description: Diclofenac sodium 1 topical patches will be compared against placebo patches.
arm group label: Diclofenac Sodium Active Topical Patch 2
arm group type: Experimental
description: Diclofenac sodium 2 topical patches will be compared against placebo patches.
intervention type: Drug
intervention name: Diclofenac Sodium Active Topical Patch 1
description: HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s)
arm group label: Diclofenac Sodium Active Topical Patch 1
other name: HP-5000
intervention type: Drug
intervention name: Diclofenac Sodium Active Topical Patch 2
description: HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s)
arm group label: Diclofenac Sodium Active Topical Patch 2
other name: HP-5000
intervention type: Drug
intervention name: Placebo patch
description: Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)
arm group label: Diclofenac Sodium Active Topical Patch 1
arm group label: Diclofenac Sodium Active Topical Patch 2
other name: Placebo treatment
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Gunnar Klauss, MD, MSc
role: Study Director
affiliation: Noven Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Diclofenac
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 