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/NCT05997979</url>
    </required_header>
    <id_info>
      <org_study_id>29BRC21.0184</org_study_id>
      <nct_id>NCT05997979</nct_id>
    </id_info>
    <brief_title>Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children</brief_title>
    <acronym>CAPSAPED</acronym>
    <official_title>Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Brest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Brest</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>
        This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after&#xD;
        trauma or surgery.&#xD;
  &#xD;
        It is a multicentric randomized controlled superiority trial in parallel arms :&#xD;
  &#xD;
          -  experimental arm: Capsaicin 8% cutaneous patch&#xD;
  &#xD;
          -  controlled arm : Hydrocolloid dressing&#xD;
  &#xD;
        Treatment with capsaicin application is realized at baseline, and repeated 3 months after the&#xD;
        first patch application if needed.&#xD;
  &#xD;
        Tolerance is assessed during each application and by phone call in following days until stop&#xD;
        of cold need.&#xD;
  &#xD;
        Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the&#xD;
        designed investigation centers for a local chronic neuropathic pain lasting more than 2&#xD;
        months after trauma or surgery are proposed to participate the trial.&#xD;
  &#xD;
        Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) &gt; or = 3/7 ou&#xD;
        DN4 &gt;or = 4/10) despite oral treatment following recommendations for neuropathic pain may be&#xD;
        enrolled in the study.&#xD;
  &#xD;
        For children not very painful (NRS-11 (Numeric Rating Scale) &lt; 7 and FDI (Functional&#xD;
        Disability Inventory) &lt; 30) and without any oral treatment for neuropathic pain, the study&#xD;
        may be proposed as first line treatment.&#xD;
  &#xD;
        If both the child and his/her parents accept the trial, he/she will be included in the study.&#xD;
  &#xD;
        It is a multicentric randomized controlled superiority trial in parallel arms :&#xD;
  &#xD;
          -  experimental arm: Capsaicin 8% cutaneous patch&#xD;
  &#xD;
          -  controlled arm : Hydrocolloid dressing&#xD;
  &#xD;
        At M0, take place : baseline evaluation, agreement consent signature, inclusion and&#xD;
        randomization, as well as first treatment application either capsaicin cutaneous patch or&#xD;
        hydrocolloid dressing.&#xD;
  &#xD;
        , If needed, the treatment may be done twice with a second application three months later&#xD;
        (M3).&#xD;
  &#xD;
        Tolerance is assessed during each application and by phone call in following days until stop&#xD;
        of cold need.&#xD;
  &#xD;
        Efficacy is assessed monthly by clinical consultation until the end of the study 4 months&#xD;
        later (M4).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2026</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>Multicentric randomized controlled superiority trial in parallel arms:&#xD;
  experimental arm : Capsaicin 8% cutaneous patch&#xD;
  control arm : Hydrocolloid dressing</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>There is no mock cutaneous patch available for capsaicin 8% cutaneous patch. So we have chosen hydrocolloid dressing for placebo since it has no known effect on neuropathic pain and the tolerability is expected as excellent.&#xD;
  The patient should not be aware of the specific aspect of capsaicin 8% patch and the protocol of application will be exactly the same. This should keep the patient blinded for the study treatment.&#xD;
  The nurse who applies the patch is unblinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The change in Neuropathic Pain Symptom Inventory score (NPSI)</measure>
      <time_frame>At baseline (day of the patch application) and 4 months after patch application</time_frame>
      <description>The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4).&#xD;
  NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse event monitoring</measure>
      <time_frame>At day 0, day 1, day 2, day 3 after patch application</time_frame>
      <description>Adverse event monitoring are collected during patch application and by phone calls in the following days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vital signs</measure>
      <time_frame>At baseline, Month 1, Month 2, Month 3 and Month 4</time_frame>
      <description>Cardiac frequency in Bpm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vital signs</measure>
      <time_frame>At baseline, Month 1, Month 2, Month 3 and Month 4</time_frame>
      <description>Arterial pressure in mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dermal assessment</measure>
      <time_frame>At baseline</time_frame>
      <description>Dermal assessment is evaluated with question concerning the treated area (YES/NO)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dermal assessment</measure>
      <time_frame>Month 1, Month 2, Month 3 and Month 4</time_frame>
      <description>Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment related pain and use of analgesic medication</measure>
      <time_frame>At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4</time_frame>
      <description>Intake of analgesic medication (YES/NO)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of patch application</measure>
      <time_frame>During patch application : at baseline and at Month 3 if it is applicable</time_frame>
      <description>Duration of patch application in minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropathic Pain Symptom Inventory score (NPSI)</measure>
      <time_frame>At baseline, Month 1, Month 2, Month 3 and Month 4</time_frame>
      <description>Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional disability evaluation (FDI)</measure>
      <time_frame>At baseline, Month 1, Month 2, Month 3 and Month 4</time_frame>
      <description>Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Neuropathic Pain</condition>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>QUTENZA</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The experimental product is QUTENZA®, a cutaneous patch which contains 179 mg of capsaicin (capsaicin 8%).The patch measures 14 cm x 20 cm.&#xD;
  The second application takes place three months after the first application.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The placebo comparator is a hydrocolloid dressing: COMFEEL PLUS TRANSPARENT, a medical device class IIb commercialized by Coloplast. The patch measures 15 cm x 15 cm.&#xD;
  The second application takes place three months after the first application.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capsaicin 8% patch</intervention_name>
      <description>Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.</description>
      <arm_group_label>QUTENZA</arm_group_label>
      <other_name>QUTENZA®</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hydrocolloid dressing</intervention_name>
      <description>Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>COMFEEL PLUS TRANSPARENT</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI&#xD;
               full filling).&#xD;
  &#xD;
            -  Male or female.&#xD;
  &#xD;
            -  Persistent neuropathic pain more than 3 months after surgery or trauma despite&#xD;
               treatment following recommendations.&#xD;
  &#xD;
            -  Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and&#xD;
               localized in a nerve territory explained by the surgery or the trauma.&#xD;
  &#xD;
            -  Treatment, survey and follow up must be realized in an identified investigating center&#xD;
               of the study&#xD;
  &#xD;
            -  For patients of childbearing potential: use of an adequate method of contraception*&#xD;
               during the course of the study through 48 hours after the last patch application&#xD;
               (girls of childbearing potential must have a negative serum or urine pregnancy test&#xD;
               within 7 days prior to the first patch application).&#xD;
  &#xD;
                 -  Adequate contraception includes sexual abstinence, progestogen-only oral hormonal&#xD;
                    contraception, where inhibition of ovulation is not the primary mode of action,&#xD;
                    male or female condom with or without spermicide, cap, diaphragm or sponge with&#xD;
                    spermicide, combination of male condom with either cap, diaphragm or sponge with&#xD;
                    spermicide (double barrier methods)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intellectual deficiency not allowing full filling of NPSI.&#xD;
  &#xD;
            -  Insufficient command of the French language to full fill NPSI and other evaluation&#xD;
               tools.&#xD;
  &#xD;
            -  Parents' refusal of consent.&#xD;
  &#xD;
            -  Minor patients' opposition.&#xD;
  &#xD;
            -  Underlying neurological disease.&#xD;
  &#xD;
            -  Ongoing neurotoxic treatment.&#xD;
  &#xD;
            -  Already treated by capsaicin.&#xD;
  &#xD;
            -  Cutaneous lesion on pain area.&#xD;
  &#xD;
            -  Patient presenting a pain area on the face, above the hairline of the scalp, and/or in&#xD;
               proximity to mucous membranes&#xD;
  &#xD;
            -  Hypersensitivity to the active substance or to any of the excipients listed in section&#xD;
               6.1 of Qutenza SmPC.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Philippe J LE MOINE, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU of Brest</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Philippe J LE MOINE, MD</last_name>
      <phone>+33298223956</phone>
      <email>philippe.lemoine@chu-brest.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU d'Amiens</name>
        <address>
          <city>Amiens</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Catherine DEVOLDERE</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU d'Angers</name>
        <address>
          <city>Angers</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Petronela RACHIERU</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Bordeaux</name>
        <address>
          <city>Bordeaux</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Sylvie BERCIAUD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Brest</name>
        <address>
          <city>Brest</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Philippe LE MOINE</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Nantes</name>
        <address>
          <city>Brest</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marine LETELLIER</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Lyon</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Sabine SIMONIN</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Marseille</name>
        <address>
          <city>Marseille</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Cécile MAREAU</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Montpellier</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Frédéric BERNARD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Toulouse</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Agnès SUC</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut Gustave Roussy</name>
        <address>
          <city>Villejuif</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marie-Anne SEVEQUE</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neuropathic Pain</keyword>
    <keyword>Pediatric</keyword>
    <keyword>Capsaicin</keyword>
    <keyword>Randomized clinical trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuralgia</mesh_term>
      <mesh_term>Chronic Pain</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>Yes</sharing_ipd>
      <ipd_description>All collected data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available beginning three years and ending fifteen years following the final study report completion</ipd_time_frame>
      <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
    </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/NCT05997979
  org study id: 29BRC21.0184
  nct id: NCT05997979
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after
        trauma or surgery.
  
        It is a multicentric randomized controlled superiority trial in parallel arms :
  
          -  experimental arm: Capsaicin 8% cutaneous patch
  
          -  controlled arm : Hydrocolloid dressing
  
        Treatment with capsaicin application is realized at baseline, and repeated 3 months after the
        first patch application if needed.
  
        Tolerance is assessed during each application and by phone call in following days until stop
        of cold need.
  
        Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).
  Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the
        designed investigation centers for a local chronic neuropathic pain lasting more than 2
        months after trauma or surgery are proposed to participate the trial.
  
        Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) > or = 3/7 ou
        DN4 >or = 4/10) despite oral treatment following recommendations for neuropathic pain may be
        enrolled in the study.
  
        For children not very painful (NRS-11 (Numeric Rating Scale) < 7 and FDI (Functional
        Disability Inventory) < 30) and without any oral treatment for neuropathic pain, the study
        may be proposed as first line treatment.
  
        If both the child and his/her parents accept the trial, he/she will be included in the study.
  
        It is a multicentric randomized controlled superiority trial in parallel arms :
  
          -  experimental arm: Capsaicin 8% cutaneous patch
  
          -  controlled arm : Hydrocolloid dressing
  
        At M0, take place : baseline evaluation, agreement consent signature, inclusion and
        randomization, as well as first treatment application either capsaicin cutaneous patch or
        hydrocolloid dressing.
  
        , If needed, the treatment may be done twice with a second application three months later
        (M3).
  
        Tolerance is assessed during each application and by phone call in following days until stop
        of cold need.
  
        Efficacy is assessed monthly by clinical consultation until the end of the study 4 months
        later (M4).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Multicentric randomized controlled superiority trial in parallel arms:
  experimental arm : Capsaicin 8% cutaneous patch
  control arm : Hydrocolloid dressing
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: There is no mock cutaneous patch available for capsaicin 8% cutaneous patch. So we have chosen hydrocolloid dressing for placebo since it has no known effect on neuropathic pain and the tolerability is expected as excellent.
  The patient should not be aware of the specific aspect of capsaicin 8% patch and the protocol of application will be exactly the same. This should keep the patient blinded for the study treatment.
  The nurse who applies the patch is unblinded.
  measure: The change in Neuropathic Pain Symptom Inventory score (NPSI)
  time frame: At baseline (day of the patch application) and 4 months after patch application
  description: The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4).
  NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome.
  measure: Adverse event monitoring
  time frame: At day 0, day 1, day 2, day 3 after patch application
  description: Adverse event monitoring are collected during patch application and by phone calls in the following days.
  measure: Vital signs
  time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
  description: Cardiac frequency in Bpm
  measure: Vital signs
  time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
  description: Arterial pressure in mmHg
  measure: Dermal assessment
  time frame: At baseline
  description: Dermal assessment is evaluated with question concerning the treated area (YES/NO)
  measure: Dermal assessment
  time frame: Month 1, Month 2, Month 3 and Month 4
  description: Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO)
  measure: Treatment related pain and use of analgesic medication
  time frame: At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4
  description: Intake of analgesic medication (YES/NO)
  measure: Duration of patch application
  time frame: During patch application : at baseline and at Month 3 if it is applicable
  description: Duration of patch application in minutes
  measure: Neuropathic Pain Symptom Inventory score (NPSI)
  time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
  description: Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome
  measure: Functional disability evaluation (FDI)
  time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
  description: Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome
  arm group label: QUTENZA
  arm group type: Active Comparator
  description: The experimental product is QUTENZA®, a cutaneous patch which contains 179 mg of capsaicin (capsaicin 8%).The patch measures 14 cm x 20 cm.
  The second application takes place three months after the first application.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: The placebo comparator is a hydrocolloid dressing: COMFEEL PLUS TRANSPARENT, a medical device class IIb commercialized by Coloplast. The patch measures 15 cm x 15 cm.
  The second application takes place three months after the first application.
  intervention type: Drug
  intervention name: Capsaicin 8% patch
  description: Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.
  arm group label: QUTENZA
  other name: QUTENZA®
  intervention type: Device
  intervention name: Hydrocolloid dressing
  description: Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.
  arm group label: Placebo
  other name: COMFEEL PLUS TRANSPARENT
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Philippe J LE MOINE, MD
  role: Principal Investigator
  affiliation: CHU of Brest
  last name: Philippe J LE MOINE, MD
  phone: +33298223956
  email: philippe.lemoine@chu-brest.fr
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Neuralgia
  mesh term: Chronic Pain
  mesh term: Capsaicin
  sharing ipd: Yes
  ipd description: All collected data that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: Data will be available beginning three years and ending fifteen years following the final study report completion
  ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.