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/NCT06023706</url>
    </required_header>
    <id_info>
      <org_study_id>RC22_0415</org_study_id>
      <nct_id>NCT06023706</nct_id>
    </id_info>
    <brief_title>Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.</brief_title>
    <acronym>CAPSACOX</acronym>
    <official_title>Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch&#xD;
        (Qutenza) for the treatment of patients with coccygodyinia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial is a French, multicenter, randomized, controlled, bouble-blind and prospective&#xD;
        study. Patients enrolled will be clinically followed for 5 months. The treatment duration per&#xD;
        subject is 1 hour (1time).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2027</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.</measure>
      <time_frame>Day 60</time_frame>
      <description>The difference in the proportion of subjects improved (PGIC≤2) in either treatment group at day 60. It is expected that there will be a difference of at least 20% between treatment arms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days</measure>
      <time_frame>time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and through study completion (an average of 5 months)</time_frame>
      <description>Tolerability will be assessed by the evolution over time of the pain intensity in standing position in the treated zone as measured on an 11 point numeric rating scale at time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study.</measure>
      <time_frame>Throughout the study (an average of 5 months)</time_frame>
      <description>Safety will be assessed by recording and describing adverse events throughout the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study.</measure>
      <time_frame>Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.</time_frame>
      <description>The timecourse of the analgesic effect will be measured by the Patients' Global Impression of Change (PGIC) scale and the area under the pain intensity score in sitting position as measured Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).</measure>
      <time_frame>Over 5 months</time_frame>
      <description>Care consumption will be assessed over 5 months using the Medication Quantification Scale (MQS), which provides a standardised assessment of consumption of analgesics and co-antalgesics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).</measure>
      <time_frame>Over 5 months</time_frame>
      <description>Care consumption will be assessed over 5 months using a self-diary in which patients will enter the dates of medical consultations (psychiatry, rheumatology, general medicine, etc.), para-medical consultations and/or complementary medical consultations (physiotherapy, acupuncture, osteopathy, psychotherapy, etc.).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months</measure>
      <time_frame>Over a time horizon of 5 months</time_frame>
      <description>The evaluation of cost-utility will be assessed as the ratio of the incremental cost-utility (RICU in cost per QALY gained) comparing the treatment with 8% capsaicin patch with usual practice according to the collective perspective and a 5-month horizon. QALYS will be calculated using patients' lifespan and a utility score obtained from responses to the EQ-5D-5L generic quality of life questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.</measure>
      <time_frame>At inclusion</time_frame>
      <description>Subgroup analysis according to the presence or absence of a sacrococcygeal mobility disorder at inclusion for the primary endpoint and the first two secondary endpoints.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of the therapeutic response to 8% capsaicin patch</measure>
      <time_frame>Day 60</time_frame>
      <description>Measurement of the association between the patient's intrinsic clinical parameters and a therapeutic response to capsaicin defined by a PGIC ≤2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity study to compare results on the primary endpoint by comparing data from the PGI-C and a comparison of the two numerical pain assessments at Day 0 and Day 60.</measure>
      <time_frame>Between Day 0 and Day 60</time_frame>
      <description>Comparison of the classification of patients as success-failure between PGI-C values at Day 60 (success if PGI-C≤2) and numerical pain assessments between Day 0 and Day 60 (success if there is a reduction of at least 2 points on the EN).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">188</enrollment>
    <condition>Coccyx Disorder</condition>
    <condition>Neuropathic Pain</condition>
    <condition>Coccygodynia</condition>
    <arm_group>
      <arm_group_label>Capsaicin 179 mg cutaneous patch</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Capsaicin 179 mg cutaneous patch.&#xD;
  1 patch applied once for 1 hour at inclusion visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Capsaicin low concentration patch</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Capsaicin 0.04 cutaneous patch.&#xD;
  1 patch applied once for 1 hour at inclusion visit</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capsaicin 179 Mg Cutaneous Patch</intervention_name>
      <description>1 patch applied once for 1 hour</description>
      <arm_group_label>Capsaicin 179 mg cutaneous patch</arm_group_label>
      <other_name>qutenza</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)</intervention_name>
      <description>1 patch applied once for 1 hour</description>
      <arm_group_label>Capsaicin low concentration patch</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;18 years old at the pre-inclusion visit&#xD;
  &#xD;
            -  Presenting with chronic coccygodynia: pain in the coccygeal region, increased by&#xD;
               sitting and or when rising from a sitting position and pain over the last ten days of&#xD;
               intensity greater than or equal to four on the eleven-point numerical scale (from zero&#xD;
               to ten) and having been present for more than 3 months.&#xD;
  &#xD;
            -  Failure of previous treatments: NSAIDs, pressure-relieving cushions, infiltration (for&#xD;
               hypermobile coccygodynia)&#xD;
  &#xD;
            -  Have never been treated with an 8% capsaicin patch for this indication&#xD;
  &#xD;
            -  With at least one clinical sign suggestive of neuropathic pain (burning, painful cold,&#xD;
               numbness, tingling, electric discharge, allodynia of the gluteal groove, allodynia to&#xD;
               pressure on the coccyx)&#xD;
  &#xD;
            -  Proficiency in reading and writing the French language&#xD;
  &#xD;
            -  Be affiliated to the social security system&#xD;
  &#xD;
            -  Have signed an informed consent form&#xD;
  &#xD;
            -  Women must meet one of the following criteria at the time of inclusion:&#xD;
  &#xD;
            -  be using adequate contraceptive measures, and have a negative pregnancy test (specify&#xD;
               if urine or blood test) prior to receiving the first dose of trial medication;&#xD;
  &#xD;
            -  or be post-menopausal (aged over 50 with amenorrhoea for at least 12 months after&#xD;
               stopping all exogenous hormonal treatments)&#xD;
  &#xD;
            -  or (if under 50) have been in amenorrhoea for at least 12 months after stopping all&#xD;
               exogenous hormone treatments and with luteinising hormone (LH) and follicle&#xD;
               stimulating hormone (FSH) levels corresponding to post-menopausal levels.&#xD;
  &#xD;
            -  or have undergone irreversible surgical sterilisation by hysterectomy, bilateral&#xD;
               oophorectomy or bilateral salpingectomy (this operation must be documented).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Coccygodynia accompanied by a dermatological lesion in the intergluteal cleft&#xD;
               (psoriasis, pilodinial cyste, wound)&#xD;
  &#xD;
            -  Patients with other major pain disorders likely to interfere with pain assessment&#xD;
  &#xD;
            -  Hypersensitivity to capsaicin or to one of the excipients&#xD;
  &#xD;
            -  Adults under legal protection (guardianship, curatorship, legal protection)&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#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_contact>
      <last_name>Amélie LEVESQUE, MD</last_name>
      <phone>+33240083912</phone>
      <email>amelie.levesque@chu-nantes.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Brest University Hospital</name>
        <address>
          <city>Brest</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Bertrand QUINIO, MD</last_name>
      </contact>
      <investigator>
        <last_name>Bertrand QUINIO, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Vendée Departmental Hospital</name>
        <address>
          <city>La Roche-sur-Yon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Yves-Marie PLUCHON, MD</last_name>
      </contact>
      <investigator>
        <last_name>Yves-Marie PLUCHON, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Confluent Private Hospital Centre</name>
        <address>
          <city>Nantes</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Thibault RIANT, MD</last_name>
      </contact>
      <investigator>
        <last_name>Thibault RIANT, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nantes University Hospital</name>
        <address>
          <city>Nantes</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Amélie LEVESQUE, MD</last_name>
      </contact>
      <investigator>
        <last_name>Amélie LEVESQUE, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GH Paris saint Joseph</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marguerite D'USSEL, MD</last_name>
      </contact>
      <investigator>
        <last_name>Marguerite D'USSEL, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rouen University Hospital</name>
        <address>
          <city>Rouen</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Rodrigue DELEENS, MD</last_name>
      </contact>
      <investigator>
        <last_name>Rodrigue DELEENS, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</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>Capsaicin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06023706
  org study id: RC22_0415
  nct id: NCT06023706
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch
        (Qutenza) for the treatment of patients with coccygodyinia.
  This trial is a French, multicenter, randomized, controlled, bouble-blind and prospective
        study. Patients enrolled will be clinically followed for 5 months. The treatment duration per
        subject is 1 hour (1time).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Double-blind
  measure: to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
  time frame: Day 60
  description: The difference in the proportion of subjects improved (PGIC≤2) in either treatment group at day 60. It is expected that there will be a difference of at least 20% between treatment arms.
  measure: Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days
  time frame: time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and through study completion (an average of 5 months)
  description: Tolerability will be assessed by the evolution over time of the pain intensity in standing position in the treated zone as measured on an 11 point numeric rating scale at time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.
  measure: Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study.
  time frame: Throughout the study (an average of 5 months)
  description: Safety will be assessed by recording and describing adverse events throughout the study.
  measure: Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study.
  time frame: Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
  description: The timecourse of the analgesic effect will be measured by the Patients' Global Impression of Change (PGIC) scale and the area under the pain intensity score in sitting position as measured Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
  measure: Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
  time frame: Over 5 months
  description: Care consumption will be assessed over 5 months using the Medication Quantification Scale (MQS), which provides a standardised assessment of consumption of analgesics and co-antalgesics.
  measure: Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
  time frame: Over 5 months
  description: Care consumption will be assessed over 5 months using a self-diary in which patients will enter the dates of medical consultations (psychiatry, rheumatology, general medicine, etc.), para-medical consultations and/or complementary medical consultations (physiotherapy, acupuncture, osteopathy, psychotherapy, etc.).
  measure: Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months
  time frame: Over a time horizon of 5 months
  description: The evaluation of cost-utility will be assessed as the ratio of the incremental cost-utility (RICU in cost per QALY gained) comparing the treatment with 8% capsaicin patch with usual practice according to the collective perspective and a 5-month horizon. QALYS will be calculated using patients' lifespan and a utility score obtained from responses to the EQ-5D-5L generic quality of life questionnaire.
  measure: Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.
  time frame: At inclusion
  description: Subgroup analysis according to the presence or absence of a sacrococcygeal mobility disorder at inclusion for the primary endpoint and the first two secondary endpoints.
  measure: Determination of the therapeutic response to 8% capsaicin patch
  time frame: Day 60
  description: Measurement of the association between the patient's intrinsic clinical parameters and a therapeutic response to capsaicin defined by a PGIC ≤2.
  measure: Sensitivity study to compare results on the primary endpoint by comparing data from the PGI-C and a comparison of the two numerical pain assessments at Day 0 and Day 60.
  time frame: Between Day 0 and Day 60
  description: Comparison of the classification of patients as success-failure between PGI-C values at Day 60 (success if PGI-C≤2) and numerical pain assessments between Day 0 and Day 60 (success if there is a reduction of at least 2 points on the EN).
  arm group label: Capsaicin 179 mg cutaneous patch
  arm group type: Experimental
  description: Capsaicin 179 mg cutaneous patch.
  1 patch applied once for 1 hour at inclusion visit.
  arm group label: Capsaicin low concentration patch
  arm group type: Placebo Comparator
  description: Capsaicin 0.04 cutaneous patch.
  1 patch applied once for 1 hour at inclusion visit
  intervention type: Drug
  intervention name: Capsaicin 179 Mg Cutaneous Patch
  description: 1 patch applied once for 1 hour
  arm group label: Capsaicin 179 mg cutaneous patch
  other name: qutenza
  intervention type: Drug
  intervention name: Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
  description: 1 patch applied once for 1 hour
  arm group label: Capsaicin low concentration patch
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amélie LEVESQUE, MD
  phone: +33240083912
  email: amelie.levesque@chu-nantes.fr
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
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  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Neuralgia
  mesh term: Capsaicin
  sharing ipd: Undecided