<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/NCT02205229</url>
  </required_header>
  <id_info>
    <org_study_id>Medimix Pharm-03</org_study_id>
    <nct_id>NCT02205229</nct_id>
  </id_info>
  <brief_title>Compounded Pain Preparation Absorption Study</brief_title>
  <acronym>ComPASS</acronym>
  <official_title>Compounded Pain Preparation Absorption Study (ComPPAS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medimix Specialty Pharmacy, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medimix Specialty Pharmacy, LLC</source>
  <brief_summary>
    <textblock>
      Single center, prospective, observational study to assess serum concentration of ingredients&#xD;
      used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single center, prospective, observational, open-label, cohort study of participants that&#xD;
      receive a combination topical pain medication from Medimix Specialty Pharmacy with no&#xD;
      comparator group designed to assess serum concentration of ingredients used in&#xD;
      multi-ingredient, topical compounded medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Serum concentration of ingredients used in multi-ingredient, topical compounded medications</measure>
    <time_frame>1 Month</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Patients receiving a topical compounded medication</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multi-ingredient, topical compounded medications</intervention_name>
    <arm_group_label>Patients receiving a topical compounded medication</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient between the ages of 30 and &lt;65 years old not taking concomitant medications that&#xD;
        may interact with study ingredients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must apply and consistently use the supplied cream for 1 month at a&#xD;
             prescribed&#xD;
&#xD;
          -  Participants must be ≥ 30 and &lt;65 years of age&#xD;
&#xD;
          -  Participants must be able to provide sound written and verbal informed consent&#xD;
&#xD;
          -  Participants must be diagnosed with an ICD9 code indicative of chronic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have prior hypersensitivity or adverse events to any of the&#xD;
             components in the customized prescription&#xD;
&#xD;
          -  Participants must not be pregnant or breastfeeding&#xD;
&#xD;
          -  Participants must not have used any study drug greater than 180 days from the day of&#xD;
             Screening&#xD;
&#xD;
          -  Participants must not be utilizing medications that may interact with those being used&#xD;
             in the topical formulation as determined by the PI&#xD;
&#xD;
          -  Participants must not be using any systemic medications that may influence drug serum&#xD;
             concentrations of ingredients being used in the topical compound. These include&#xD;
             medications from the same class of studied drugs or drugs that may falsely increase or&#xD;
             decrease serum levels of the study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medimix Specialty Pharmacy</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>May 15, 2015</last_update_submitted>
  <last_update_submitted_qc>May 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02205229
org study id: Medimix Pharm-03
nct id: NCT02205229
lead sponsor: 
Single center, prospective, observational study to assess serum concentration of ingredients
      used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.
Single center, prospective, observational, open-label, cohort study of participants that
      receive a combination topical pain medication from Medimix Specialty Pharmacy with no
      comparator group designed to assess serum concentration of ingredients used in
      multi-ingredient, topical compounded medications.
observational model: Cohort
time perspective: Prospective
measure: Serum concentration of ingredients used in multi-ingredient, topical compounded medications
time frame: 1 Month
arm group label: Patients receiving a topical compounded medication
intervention type: Drug
intervention name: Multi-ingredient, topical compounded medications
arm group label: Patients receiving a topical compounded medication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor