<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/NCT03768011</url>
  </required_header>
  <id_info>
    <org_study_id>PAS1466</org_study_id>
    <nct_id>NCT03768011</nct_id>
  </id_info>
  <brief_title>Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications</brief_title>
  <official_title>A Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications to Help Reduce or Eliminate Use of Opiates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Data Collection Analysis Business Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Data Collection Analysis Business Management</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      purpose of this study is to evaluate the level of pain perceived by patients using a&#xD;
      transdermal cream and/or transdermal patch with or without an oral medication as a pain&#xD;
      management solution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this minimal risk, observational study is to observe and document patients'&#xD;
      perspective on how the combination of transdermal cream and/or transdermal patch(s) with or&#xD;
      without oral medication can help reduce or eliminate the use of opiate(s).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring pain from 0 no pain to 10 highest pain level.</measure>
    <time_frame>36 months</time_frame>
    <description>Collecting and analyzing quantitative and qualitative data to draw generalized outcome measures, on real world data.Data from the subject surveys will analyze and measure the effectiveness through a subjective observation via patients' perspective survey on transdermal cream and/or transdermal patches with or without oral non-narcotic medication and if it helped with the reduction or elimination of opiate(s).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue scales</measure>
    <time_frame>36 months</time_frame>
    <description>By utilizing the Visual analogue scale from the patients' perspective will generate real world data</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Pain, Chronic</condition>
  <condition>Pain, Joint</condition>
  <condition>Pain Syndrome</condition>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>transdermal cream and or patch</intervention_name>
    <description>transdermal cream and/or transdermal patch(s) with or without oral medication</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        a patient with joint pain, extremity pain, lumbar, thoracic and/or cervical pain, as part&#xD;
        of the PI routine care or follows medical necessity and prescribes a combination topical&#xD;
        cream and/or patch with or without non-narcotic oral medication independent of the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be diagnosed with an ICD10 code indicative of chronic pain&#xD;
&#xD;
          -  Participants must be starting a new regimen of topical therapy with or without&#xD;
             non-narcotic oral medication that has been deemed medically necessary and is&#xD;
             independent of the study&#xD;
&#xD;
          -  Participants must be expecting to receive therapy for at least 12 weeks&#xD;
&#xD;
          -  Participants must be between 18 and 64 years of age&#xD;
&#xD;
          -  Participants must be able to provide sound verbal informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not be a beneficiary of government funded healthcare program (i.e.&#xD;
             Medicare, Medicaid, etc.)&#xD;
&#xD;
          -  Participants must not have a diagnosis of cancer within the past 5 years&#xD;
&#xD;
          -  Participants who have chronic pain conditions not expected to respond to topical pain&#xD;
             medication such as deep abdominal pain, or from conditions such as cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DCABM</name>
      <address>
        <city>Land O' Lakes</city>
        <state>Florida</state>
        <zip>33558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 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>Arthralgia</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03768011
org study id: PAS1466
nct id: NCT03768011
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
purpose of this study is to evaluate the level of pain perceived by patients using a
      transdermal cream and/or transdermal patch with or without an oral medication as a pain
      management solution.
The purpose of this minimal risk, observational study is to observe and document patients'
      perspective on how the combination of transdermal cream and/or transdermal patch(s) with or
      without oral medication can help reduce or eliminate the use of opiate(s).
observational model: Cohort
time perspective: Prospective
measure: Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring pain from 0 no pain to 10 highest pain level.
time frame: 36 months
description: Collecting and analyzing quantitative and qualitative data to draw generalized outcome measures, on real world data.Data from the subject surveys will analyze and measure the effectiveness through a subjective observation via patients' perspective survey on transdermal cream and/or transdermal patches with or without oral non-narcotic medication and if it helped with the reduction or elimination of opiate(s).
measure: Visual Analogue scales
time frame: 36 months
description: By utilizing the Visual analogue scale from the patients' perspective will generate real world data
intervention type: Combination Product
intervention name: transdermal cream and or patch
description: transdermal cream and/or transdermal patch(s) with or without oral medication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthralgia
mesh term: Chronic Pain
sharing ipd: Undecided