<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/NCT02193711</url>
  </required_header>
  <id_info>
    <org_study_id>Delivra-001</org_study_id>
    <nct_id>NCT02193711</nct_id>
  </id_info>
  <brief_title>Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee</brief_title>
  <official_title>Randomized, Double Blind, Placebo Controlled Trial With Open Label Extension Of Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Delivra, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Delivra, Inc.</source>
  <brief_summary>
    <textblock>
      The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy&#xD;
      of a topical cream compared to a placebo cream. The study population will be those with mild&#xD;
      to moderate osteoarthritis of the knee.&#xD;
&#xD;
      The trial will also provide information about potential side effects and verify the safety of&#xD;
      this composition. Blood levels will be done to assess inflammation and to determine whether&#xD;
      any systemic absorption has occurred.&#xD;
&#xD;
      Hypothesis/Purpose&#xD;
&#xD;
        -  Pain scores after active treatment will be significantly reduced in comparison to&#xD;
           placebo.&#xD;
&#xD;
        -  There will be an improvement in stiffness and physical function as measured by the WOMAC&#xD;
           using the active cream as compared to placebo.&#xD;
&#xD;
        -  There will be a decrease in the level of inflammation assessed at baseline, end of week&#xD;
           3 and end of week 6.&#xD;
&#xD;
        -  The blood concentration of the active ingredient in the topical cream will not exceed&#xD;
           the maximum daily dose that will be consumed by participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean daily pain diary score from baseline</measure>
    <time_frame>three weeks</time_frame>
    <description>The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WOMAC</measure>
    <time_frame>Six weeks</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis Index is a well validated and widely used measure to assess pain, stiffness and physical function in individuals with OA of the knee or hip. It consists of 24 questions divided into 3 scales (pain, stiffness and physical function). This scale has been found to be sensitive to interventions used for osteoarthritis and is noted by IMMPACT as an example of an appropriate disease specific measure of physical function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BPI-SF</measure>
    <time_frame>six weeks</time_frame>
    <description>The BPI pain scale has been widely used and found to provide a reliable and valid measure of pain and pain's interference with physical functioning in seven areas including: general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life. The instrument consists of a series of 11-point numeric rating scales asking the participant to rate the pain and indicate how much the pain has interfered with seven areas (0 indicating &quot;does not interfere&quot;, 10 indicating &quot;completely interferes&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGIC</measure>
    <time_frame>six weeks</time_frame>
    <description>The Patient Global Impression of Change Scale (PGIC). This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from &quot;very much improved' to &quot;very much worse&quot; with &quot;no-change, as the mid-point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGSS</measure>
    <time_frame>six weeks</time_frame>
    <description>The Patient Global Satisfaction Scale (PGSS) is a 10-point scale with verbal descriptors ranging from &quot;very satisfied&quot; to &quot;not at all satisfied.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Topical Arthritis Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Topical Arthritis Cream</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Topical Arthritis Cream</arm_group_label>
    <other_name>LivRelief Pharmax Rebuild</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Osteoarthritis of the knee according to American College of Rheumatology criteria:&#xD;
             Knee pain with 3:&#xD;
&#xD;
               -  age &gt;50 years&#xD;
&#xD;
               -  stiffness less than 30 min&#xD;
&#xD;
               -  crepitus,&#xD;
&#xD;
               -  bony tenderness,&#xD;
&#xD;
               -  bony enlargement,&#xD;
&#xD;
               -  no palpable warmth&#xD;
&#xD;
          -  Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0&#xD;
             on an 11-point numerical rating scale for pain intensity (NRS-PI).&#xD;
&#xD;
          -  All concurrent medications taken for any reason stable for 14 days&#xD;
&#xD;
          -  Ability to follow protocol with reference to cognitive and situational factors (eg.&#xD;
             stable housing, ability to attend visits)&#xD;
&#xD;
          -  Ability to read and write English&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently taking opioids, NSAIDs, warfarin, other anticoagulants, other topical agents&#xD;
             for treatment of pain or inflammation&#xD;
&#xD;
          -  Allergy to tea tree oil, latex, avocado, soy&#xD;
&#xD;
          -  Active conditions such as exzema or psoriasis&#xD;
&#xD;
          -  Presence of significant medical disorder that would compromise the participant's&#xD;
             safety to take part in the trial (eg. cancer, immunosuppressed)&#xD;
&#xD;
          -  Individuals with a history or current disease which may affect the outcome of the&#xD;
             trial (ie. Inflammatory, infections joint disease).&#xD;
&#xD;
          -  Allergy to plants of the Asteraceae/Compositae/Daisy family.&#xD;
&#xD;
          -  Pregnant and breastfeeding women.&#xD;
&#xD;
          -  Allergy or other contraindication for acetaminophen use.&#xD;
&#xD;
          -  Exercise or transcutaneous electrical nerve stimulation should be excluded prior to&#xD;
             and during the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CDHA - Pain Management Unit</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canadian College of Naturopathic Medicine</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M2K 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02193711
org study id: Delivra-001
nct id: NCT02193711
lead sponsor: 
The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy
      of a topical cream compared to a placebo cream. The study population will be those with mild
      to moderate osteoarthritis of the knee.

      The trial will also provide information about potential side effects and verify the safety of
      this composition. Blood levels will be done to assess inflammation and to determine whether
      any systemic absorption has occurred.

      Hypothesis/Purpose

        -  Pain scores after active treatment will be significantly reduced in comparison to
           placebo.

        -  There will be an improvement in stiffness and physical function as measured by the WOMAC
           using the active cream as compared to placebo.

        -  There will be a decrease in the level of inflammation assessed at baseline, end of week
           3 and end of week 6.

        -  The blood concentration of the active ingredient in the topical cream will not exceed
           the maximum daily dose that will be consumed by participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in mean daily pain diary score from baseline
time frame: three weeks
description: The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.
measure: WOMAC
time frame: Six weeks
description: The Western Ontario and McMaster Universities Arthritis Index is a well validated and widely used measure to assess pain, stiffness and physical function in individuals with OA of the knee or hip. It consists of 24 questions divided into 3 scales (pain, stiffness and physical function). This scale has been found to be sensitive to interventions used for osteoarthritis and is noted by IMMPACT as an example of an appropriate disease specific measure of physical function.
measure: BPI-SF
time frame: six weeks
description: The BPI pain scale has been widely used and found to provide a reliable and valid measure of pain and pain's interference with physical functioning in seven areas including: general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life. The instrument consists of a series of 11-point numeric rating scales asking the participant to rate the pain and indicate how much the pain has interfered with seven areas (0 indicating "does not interfere", 10 indicating "completely interferes").
measure: PGIC
time frame: six weeks
description: The Patient Global Impression of Change Scale (PGIC). This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from "very much improved' to "very much worse" with "no-change, as the mid-point.
measure: PGSS
time frame: six weeks
description: The Patient Global Satisfaction Scale (PGSS) is a 10-point scale with verbal descriptors ranging from "very satisfied" to "not at all satisfied.
arm group label: Topical Arthritis Cream
arm group type: Experimental
description: 1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.
arm group label: Placebo
arm group type: Placebo Comparator
description: 1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.
intervention type: Other
intervention name: Topical Arthritis Cream
arm group label: Placebo
arm group label: Topical Arthritis Cream
other name: LivRelief Pharmax Rebuild
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee