<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/NCT02195752</url>
  </required_header>
  <id_info>
    <org_study_id>LIS001</org_study_id>
    <nct_id>NCT02195752</nct_id>
  </id_info>
  <brief_title>Lexington Observational Study of Treatment With Compounded Pain Creams</brief_title>
  <acronym>TrackingCPC</acronym>
  <official_title>Observational Study of Patient and Physician Experiences During Treatment of Pain With Compounded Pharmaceuticals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lexington Independent Studies, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Palm Beach CRO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lexington Independent Studies, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients&#xD;
      prescribed compounded pharmaceutical creams for the treatment of pain. The project is&#xD;
      designed to accumulate tracking information from both patients and physicians over the course&#xD;
      of therapy as a supplement to the ordinary care that the patients will normally receive. We&#xD;
      seek to discover aspects of successful and unsuccessful treatment using topical pain creams.&#xD;
      This information will be analyzed and reports prepared of observations and emergent findings.&#xD;
      These reports will be sent during the study every 1 or 2 months to patients, physicians and&#xD;
      pharmacists who are participating in the Study. A final compilation of findings and&#xD;
      observations will be circulated to participating patients, physicians and pharmacists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Description Of Data Relevant to Objectives:&#xD;
&#xD;
      The primary objective of this study is to document clinical experience. Specifically, the&#xD;
      study will collect:&#xD;
&#xD;
        1. The expectations from both patient and physician. These underlie patient willingness to&#xD;
           use a topical therapy, and the physician's motivation in prescribing.&#xD;
&#xD;
        2. What is prescribed and used. The composition of compounded creams vary. Is there an&#xD;
           association between the agents / concentrations and the effects on different types of&#xD;
           pain?&#xD;
&#xD;
        3. Patterns of use of the creams. Do patients follow the prescription; do they adapt&#xD;
           frequency and location of application? Why?&#xD;
&#xD;
        4. What happens with use? Do pain scores change? How quickly, and in what ways do pain&#xD;
           scores change with different diagnoses? What is the impact on patient lives? Are&#xD;
           expectations typically fulfilled and/or are there surprises and emergent findings?&#xD;
&#xD;
        5. Observations and structured assessments to tabulate the aspects of successful and&#xD;
           unsuccessful treatment using topical pain creams of various compositions and for diverse&#xD;
           underlying complaints.&#xD;
&#xD;
        6. The level of satisfaction and perceived benefit. If treatment is discontinued, is it&#xD;
           because the problem has been resolved? Or is there burden, cost or lack of benefit?&#xD;
&#xD;
        7. Separate confidential information from patients and physicians so that the study team&#xD;
           can learn how closely the patients' observations match those of the physicians. The&#xD;
           level and nature of the correspondence between patient observations and clinician&#xD;
           observations (or lack of it) will be shared in reports sent to study participants. Such&#xD;
           reports will not disclose the identities of either physicians or patients.&#xD;
&#xD;
        8. Comments on reports. An area of interest for the study is to investigate the interest in&#xD;
           physicians and patients in the reports to be generated concerning the observations from&#xD;
           other patients and other physicians. Will patients be interested in their trajectory of&#xD;
           treatment? Will sharing the information impact the perceived value of treatment?&#xD;
&#xD;
      Registry Procedures:&#xD;
&#xD;
        1. Data capture is done at visits using structured forms developed in consultation with&#xD;
           treating physicians.&#xD;
&#xD;
        2. Patient data: Patients enter ratings and information using encoded paper forms that are&#xD;
           then sent by mail directly to the Lexington data entry service, or online using a secure&#xD;
           login to send forms to the study database. Such direct from patient transfer is intended&#xD;
           to reduce bias that would otherwise influence self assessments of treatment benefit&#xD;
           because of the desire of the patient to please the treating physician.&#xD;
&#xD;
        3. Diagnostic standards: International Statistical Classification of Diseases and Related&#xD;
           Health Problems, Ninth Revision (ICD9) or International Statistical Classification of&#xD;
           Diseases and Related Health Problems, Tenth Revision ( ICD10) codes for diagnosis of&#xD;
           pain conditions to be treated are required.&#xD;
&#xD;
        4. Checklists for each visit are completed as part of the trial record to ensure standard&#xD;
           processes are followed by treating physicians.&#xD;
&#xD;
        5. If missing or illegible data are not resolvable, then there will be NO imputation.&#xD;
           Reports and analysis will be based only on entries where source values were clear. Data&#xD;
           entry forms include range and completeness checks, prevention of illogical entry. Free&#xD;
           text fields are important for capturing unexpected events and observations. These will&#xD;
           be recorded verbatim into the database.&#xD;
&#xD;
        6. There is no primary hypothesis under test. Observations reported will include counts for&#xD;
           instances and trends. Assessments and ratings will be reported as averages and&#xD;
           distributions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor financial decision stemming from low recruitment&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 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>2 Years</target_duration>
  <primary_outcome>
    <measure>Change in patient reported pain levels following treatment</measure>
    <time_frame>One year following first patient enrolled</time_frame>
    <description>Across active subjects who have a Baseline pain level AND a followup pain level as of 1 year following first patient enrolled (FPI). Applies to the intended use of the pain cream as established by the diagnosis and area to be treated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient global impression of benefit</measure>
    <time_frame>One year after first patient enrolled</time_frame>
    <description>Assessed by a structured VAS for completion at followup and final visits. Will be assessed for all patients who have reported on the first followup visit. Mean and distribution will be reported.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Frequency that patients do NOT use the pain cream as instructed</measure>
    <time_frame>One year following first patient enrolled (FPI).</time_frame>
    <description>Both incidence (a count and percentage) and 5 most common reasons given by patients for not following the prescription will be reported. The information is proactively captured at followup visits. Baseline establishes prescribed use. Followup items probe for uses inconsistent with prescription. The population will include all subjects as of 1 year following FPI who have reported a followup visit.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Prescribed Compounded Pain Cream</arm_group_label>
    <description>The study is limited to patients who have been prescribed treatment with a topical compounded pain cream as a component of their ordinary care by a qualified physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Compounded Pain Cream</intervention_name>
    <description>All patients will have been prescribed a topical pain cream prepared by a qualified compounding pharmacy</description>
    <arm_group_label>Prescribed Compounded Pain Cream</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males and females at least 18 years of age residing in the United States&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be informed of the nature of the study and must give written informed consent&#xD;
&#xD;
          -  be able to communicate effectively with study personnel&#xD;
&#xD;
          -  be diagnosed with a condition for which the physician has prescribed a compounded pain&#xD;
             cream.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy or adverse reaction to pain cream ingredients&#xD;
&#xD;
          -  History of psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen A. Raymond, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Research and Marketing Consultants</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lido Chen</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adolphus Anekwe</name>
      <address>
        <city>Gary</city>
        <state>Indiana</state>
        <zip>46409</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 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>May 7, 2015</last_update_submitted>
  <last_update_submitted_qc>May 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Compounded pain cream</keyword>
  <keyword>Ordinary care</keyword>
  <keyword>Compounding</keyword>
  <keyword>Topical treatment</keyword>
  <keyword>Analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Acute Pain</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/NCT02195752
org study id: LIS001
nct id: NCT02195752
lead sponsor: 
collaborator: 
has dmc: No
A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients
      prescribed compounded pharmaceutical creams for the treatment of pain. The project is
      designed to accumulate tracking information from both patients and physicians over the course
      of therapy as a supplement to the ordinary care that the patients will normally receive. We
      seek to discover aspects of successful and unsuccessful treatment using topical pain creams.
      This information will be analyzed and reports prepared of observations and emergent findings.
      These reports will be sent during the study every 1 or 2 months to patients, physicians and
      pharmacists who are participating in the Study. A final compilation of findings and
      observations will be circulated to participating patients, physicians and pharmacists.
Description Of Data Relevant to Objectives:

      The primary objective of this study is to document clinical experience. Specifically, the
      study will collect:

        1. The expectations from both patient and physician. These underlie patient willingness to
           use a topical therapy, and the physician's motivation in prescribing.

        2. What is prescribed and used. The composition of compounded creams vary. Is there an
           association between the agents / concentrations and the effects on different types of
           pain?

        3. Patterns of use of the creams. Do patients follow the prescription; do they adapt
           frequency and location of application? Why?

        4. What happens with use? Do pain scores change? How quickly, and in what ways do pain
           scores change with different diagnoses? What is the impact on patient lives? Are
           expectations typically fulfilled and/or are there surprises and emergent findings?

        5. Observations and structured assessments to tabulate the aspects of successful and
           unsuccessful treatment using topical pain creams of various compositions and for diverse
           underlying complaints.

        6. The level of satisfaction and perceived benefit. If treatment is discontinued, is it
           because the problem has been resolved? Or is there burden, cost or lack of benefit?

        7. Separate confidential information from patients and physicians so that the study team
           can learn how closely the patients' observations match those of the physicians. The
           level and nature of the correspondence between patient observations and clinician
           observations (or lack of it) will be shared in reports sent to study participants. Such
           reports will not disclose the identities of either physicians or patients.

        8. Comments on reports. An area of interest for the study is to investigate the interest in
           physicians and patients in the reports to be generated concerning the observations from
           other patients and other physicians. Will patients be interested in their trajectory of
           treatment? Will sharing the information impact the perceived value of treatment?

      Registry Procedures:

        1. Data capture is done at visits using structured forms developed in consultation with
           treating physicians.

        2. Patient data: Patients enter ratings and information using encoded paper forms that are
           then sent by mail directly to the Lexington data entry service, or online using a secure
           login to send forms to the study database. Such direct from patient transfer is intended
           to reduce bias that would otherwise influence self assessments of treatment benefit
           because of the desire of the patient to please the treating physician.

        3. Diagnostic standards: International Statistical Classification of Diseases and Related
           Health Problems, Ninth Revision (ICD9) or International Statistical Classification of
           Diseases and Related Health Problems, Tenth Revision ( ICD10) codes for diagnosis of
           pain conditions to be treated are required.

        4. Checklists for each visit are completed as part of the trial record to ensure standard
           processes are followed by treating physicians.

        5. If missing or illegible data are not resolvable, then there will be NO imputation.
           Reports and analysis will be based only on entries where source values were clear. Data
           entry forms include range and completeness checks, prevention of illogical entry. Free
           text fields are important for capturing unexpected events and observations. These will
           be recorded verbatim into the database.

        6. There is no primary hypothesis under test. Observations reported will include counts for
           instances and trends. Assessments and ratings will be reported as averages and
           distributions.
observational model: Cohort
time perspective: Prospective
measure: Change in patient reported pain levels following treatment
time frame: One year following first patient enrolled
description: Across active subjects who have a Baseline pain level AND a followup pain level as of 1 year following first patient enrolled (FPI). Applies to the intended use of the pain cream as established by the diagnosis and area to be treated.
measure: Patient global impression of benefit
time frame: One year after first patient enrolled
description: Assessed by a structured VAS for completion at followup and final visits. Will be assessed for all patients who have reported on the first followup visit. Mean and distribution will be reported.
measure: Frequency that patients do NOT use the pain cream as instructed
time frame: One year following first patient enrolled (FPI).
description: Both incidence (a count and percentage) and 5 most common reasons given by patients for not following the prescription will be reported. The information is proactively captured at followup visits. Baseline establishes prescribed use. Followup items probe for uses inconsistent with prescription. The population will include all subjects as of 1 year following FPI who have reported a followup visit.
arm group label: Prescribed Compounded Pain Cream
description: The study is limited to patients who have been prescribed treatment with a topical compounded pain cream as a component of their ordinary care by a qualified physician.
intervention type: Other
intervention name: Compounded Pain Cream
description: All patients will have been prescribed a topical pain cream prepared by a qualified compounding pharmacy
arm group label: Prescribed Compounded Pain Cream
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen A. Raymond, PhD
role: Study Director
affiliation: Research and Marketing Consultants
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Acute Pain