xml: <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/NCT05983263</url>
    </required_header>
    <id_info>
      <org_study_id>CAPSACOXp_AL_06032023</org_study_id>
      <nct_id>NCT05983263</nct_id>
    </id_info>
    <brief_title>Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia</brief_title>
    <acronym>CAPSACOXp</acronym>
    <official_title>Neuropathic Determining Factors and Analgesic Efficacy of Capsaicin 8% (QUTENZA®) Patches in Refractory Coccygodygnia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nantes University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nantes University Hospital</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>
        A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin&#xD;
        patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of&#xD;
        therapeutic response.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by&#xD;
        sitting and/or by getting up from a seat. Even if there is no epidemiology of this pain in&#xD;
        France, coccygodynia represents a frequent recourse to specialized consultations&#xD;
        (Rheumatology or Algology). Currently in France, there is no recommendation on the management&#xD;
        of chronic disabling coccygodynia. Treatments are proposed in accordance with known/presumed&#xD;
        underlying pathophysiology. Anti-inflammatory drugs and manual therapy (pressure relief&#xD;
        cushions) are thus always offered as first-line treatments. But despite their common&#xD;
        use/prescription, their efficacy is variable, with low level of evidence. More over, upstream&#xD;
        of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new&#xD;
        approaches. Considering frequent neuropathic expression in coccygodynic pain pattern&#xD;
        (tingling, itching, pain cold sensation…), capsaïcine 8% patch (QUTENZA®) are often&#xD;
        performed. And in the same way, no/few researches tried to measure real-life analgesic pain&#xD;
        efficacy of QUTENZA® strategy. Observational retrospective study (non-interventional&#xD;
        anonymized data) CAPSACOXp aims to assess analgesic efficacy of Capsaicin 8% patch (QUTENZA®)&#xD;
        and explore possible neuropathic determinants of therapeutic response in coccygodynia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 21, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 17, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Responder rate</measure>
      <time_frame>3 months after the inclusion visit.</time_frame>
      <description>Success defined by PGIC ≤ 2.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Therapeutic response neuropathic predictive factors</measure>
      <time_frame>3 months after the inclusion visit</time_frame>
      <description>Identification of baseline neuropathic predictive factors (extracted from DN4 criteria) of Capsaïcine 8% efficacy at 3months (ie. PGIC ≤ 2)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">106</enrollment>
    <condition>Coccyx Disorder</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capsaicin</intervention_name>
      <description>Capsaicin 8% patch (QUTENZA) apposed in coccygeal area</description>
      <other_name>Capsaicin 8% patch</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Medical files of 106 patients hospitalized between 2016 and 2022 for persisting&#xD;
          coccygodynia (&gt;3months) and at least one neuropathic symptom in pain expression, and who&#xD;
          received capsaicin 8% patch (QUTENZA®) topical treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who received topical Capsaicin 8% patch therapy for the treatment of their&#xD;
               coccygodygnia between August 2016 and August 2022&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have already received 8% Capsaicin patch topical treatment in coccyx&#xD;
               area.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic Coccygodynia</keyword>
    <keyword>Neuropathic pain</keyword>
    <keyword>Capsaicine 8%</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Capsaicin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Anonymized dataset. No sharing.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983263
  org study id: CAPSACOXp_AL_06032023
  nct id: NCT05983263
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin
        patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of
        therapeutic response.
  Coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by
        sitting and/or by getting up from a seat. Even if there is no epidemiology of this pain in
        France, coccygodynia represents a frequent recourse to specialized consultations
        (Rheumatology or Algology). Currently in France, there is no recommendation on the management
        of chronic disabling coccygodynia. Treatments are proposed in accordance with known/presumed
        underlying pathophysiology. Anti-inflammatory drugs and manual therapy (pressure relief
        cushions) are thus always offered as first-line treatments. But despite their common
        use/prescription, their efficacy is variable, with low level of evidence. More over, upstream
        of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new
        approaches. Considering frequent neuropathic expression in coccygodynic pain pattern
        (tingling, itching, pain cold sensation…), capsaïcine 8% patch (QUTENZA®) are often
        performed. And in the same way, no/few researches tried to measure real-life analgesic pain
        efficacy of QUTENZA® strategy. Observational retrospective study (non-interventional
        anonymized data) CAPSACOXp aims to assess analgesic efficacy of Capsaicin 8% patch (QUTENZA®)
        and explore possible neuropathic determinants of therapeutic response in coccygodynia.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Responder rate
  time frame: 3 months after the inclusion visit.
  description: Success defined by PGIC ≤ 2.
  measure: Therapeutic response neuropathic predictive factors
  time frame: 3 months after the inclusion visit
  description: Identification of baseline neuropathic predictive factors (extracted from DN4 criteria) of Capsaïcine 8% efficacy at 3months (ie. PGIC ≤ 2)
  intervention type: Drug
  intervention name: Capsaicin
  description: Capsaicin 8% patch (QUTENZA) apposed in coccygeal area
  other name: Capsaicin 8% patch
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Capsaicin
  sharing ipd: No
  ipd description: Anonymized dataset. No sharing.