<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/NCT02215798</url>
  </required_header>
  <id_info>
    <org_study_id>1208.31</org_study_id>
    <nct_id>NCT02215798</nct_id>
  </id_info>
  <brief_title>Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients</brief_title>
  <official_title>Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Primary objective: To estimate the frequency of adverse events, serious and non-serious in&#xD;
      Filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg once&#xD;
      daily within the study duration of approximately 6-8 weeks in a naturalistic clinical&#xD;
      setting. Secondary objective: To evaluate the change from baseline to endpoint in the Brief&#xD;
      Pain Inventory (BPI) and Neuropathic Pain Questionnaire (NPQ) assessed by the investigators&#xD;
      in duloxetine use in the treatment of diabetic peripheral neuropathic pain among Filipino&#xD;
      patients within the study duration of approximately 6-8 weeks in a naturalistic clinical&#xD;
      setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2006</start_date>
  <primary_completion_date type="Actual">October 2009</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>Frequency of serious and non-serious adverse events</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Brief Pain Inventory (BPI)</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Neuropathic Pain Questionnaire (NPQ)</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">269</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Cymbalta</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cymbalta</intervention_name>
    <arm_group_label>Cymbalta</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Are of Filipino race&#xD;
&#xD;
          -  Are male or female outpatients at least 18 years of age&#xD;
&#xD;
          -  Provide written consent to the release of their data after being informed of the study&#xD;
&#xD;
          -  Are known diabetics and have been clinically diagnosed by the investigator to have&#xD;
             Diabetic Peripheral Neuropathic Pain&#xD;
&#xD;
          -  Are judged by the investigator to be reliable, and agree to keep appointments for&#xD;
             clinic visits, complete tests and procedures as may be required by his/her attending&#xD;
             physician in the course of routine clinical care&#xD;
&#xD;
          -  Treated with duloxetine according to the approved Product Information as prescribed by&#xD;
             the investigator in the routine care of the patient, without the concomitant&#xD;
             conditions and medications specified therein as contraindicated&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Are the investigators or their immediate families. Immediate family was defined as the&#xD;
             investigator's spouse, parents, naturally or legally adopted child (including&#xD;
             stepchild living in the investigator's household), grandparents, or grandchild.&#xD;
             Employees of investigators are also not eligible&#xD;
&#xD;
          -  Are simultaneously participating in a different study that includes a treatment&#xD;
             intervention and/or an investigational drug&#xD;
&#xD;
          -  Are hypersensitive to duloxetine or any of its components&#xD;
&#xD;
          -  Are pregnant and/or nursing mothers&#xD;
&#xD;
          -  Have concomitant conditions contraindicated for duloxetine treatment, as described in&#xD;
             the Product Information (e.g. liver disease resulting in hepatic impairment, severe&#xD;
             renal impairment)&#xD;
&#xD;
          -  Are concomitantly taking contraindicated medications, as described in the Product&#xD;
             Information (e.g. fluvoxamine, ciprofloxacin)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</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>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
  </intervention_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/NCT02215798
org study id: 1208.31
nct id: NCT02215798
lead sponsor: 
Primary objective: To estimate the frequency of adverse events, serious and non-serious in
      Filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg once
      daily within the study duration of approximately 6-8 weeks in a naturalistic clinical
      setting. Secondary objective: To evaluate the change from baseline to endpoint in the Brief
      Pain Inventory (BPI) and Neuropathic Pain Questionnaire (NPQ) assessed by the investigators
      in duloxetine use in the treatment of diabetic peripheral neuropathic pain among Filipino
      patients within the study duration of approximately 6-8 weeks in a naturalistic clinical
      setting.
observational model: Cohort
time perspective: Prospective
measure: Frequency of serious and non-serious adverse events
time frame: up to 8 weeks
measure: Change from baseline in Brief Pain Inventory (BPI)
time frame: up to 8 weeks
measure: Change from baseline in Neuropathic Pain Questionnaire (NPQ)
time frame: up to 8 weeks
arm group label: Cymbalta
intervention type: Drug
intervention name: Cymbalta
arm group label: Cymbalta
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Duloxetine Hydrochloride