<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/NCT01699854</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2012-055</org_study_id>
    <secondary_id>2012-001540-22</secondary_id>
    <nct_id>NCT01699854</nct_id>
  </id_info>
  <brief_title>Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the present study the investigators intend to investigate analgesic and sensory effects of&#xD;
      a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory&#xD;
      abnormalities in the skin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Expiration of the placebo patch&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain change capsaicin vs. placebo patch treatment</measure>
    <time_frame>Pain intensity assessed at baseline and at 1,2,3 months follow-up</time_frame>
    <description>Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days at baseline and at 1 months, 2 months and 3 months during follow-up. The primary outcome measure is the maximum difference between the summed pain intensity differences (SPID) for the phases: Baseline, 1 month, 2 month or 3 month. Δ SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in AAS (Activities Assessment Scale) score</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HADS (Hospital Anxiety and Depression Scale) score</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in QST (Quantitative sensory testing)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sleep (Sleep Interference Scale) score</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in intraepidermal nerve fiber density</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PCS (Pain Catastrophizing Scale) score</measure>
  </secondary_outcome>
  <other_outcome>
    <measure>interim analyses</measure>
    <description>An interim analysis evaluating pain change (SPID) for capsaicin patch vs. placebo treatment by an independent statistician following completion of 32 patients.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Persistent Pain After Inguinal Herniotomy</condition>
  <arm_group>
    <arm_group_label>capsaicin patch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo patch</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>capsaicin patch (qutenza)</intervention_name>
    <arm_group_label>capsaicin patch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>placebo patch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III&#xD;
&#xD;
          -  Severe post-herniotomy pain for more than six months and with severe pain (numerical&#xD;
             rating scale [NRS] 0-10 points) during rest or during movement &gt; 5.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in&#xD;
             the patches&#xD;
&#xD;
          -  Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III&#xD;
&#xD;
          -  Inflamed or injured skin at the application site&#xD;
&#xD;
          -  Signs of cognitive impairment&#xD;
&#xD;
          -  Known drug or ethanol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen Ø</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>February 25, 2014</last_update_submitted>
  <last_update_submitted_qc>February 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Joakim Bischoff</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capsaicin</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/NCT01699854
org study id: H-4-2012-055
secondary id: 2012-001540-22
nct id: NCT01699854
lead sponsor: 
has dmc: Yes
In the present study the investigators intend to investigate analgesic and sensory effects of
      a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory
      abnormalities in the skin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain change capsaicin vs. placebo patch treatment
time frame: Pain intensity assessed at baseline and at 1,2,3 months follow-up
description: Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days at baseline and at 1 months, 2 months and 3 months during follow-up. The primary outcome measure is the maximum difference between the summed pain intensity differences (SPID) for the phases: Baseline, 1 month, 2 month or 3 month. Δ SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients.
measure: Changes in AAS (Activities Assessment Scale) score
measure: Changes in HADS (Hospital Anxiety and Depression Scale) score
measure: Changes in QST (Quantitative sensory testing)
measure: Changes in sleep (Sleep Interference Scale) score
measure: Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs)
measure: Changes in intraepidermal nerve fiber density
measure: Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia
measure: Changes in PCS (Pain Catastrophizing Scale) score
measure: interim analyses
description: An interim analysis evaluating pain change (SPID) for capsaicin patch vs. placebo treatment by an independent statistician following completion of 32 patients.
arm group label: capsaicin patch
arm group type: Active Comparator
arm group label: placebo patch
arm group type: Placebo Comparator
intervention type: Drug
intervention name: capsaicin patch (qutenza)
arm group label: capsaicin patch
intervention type: Drug
intervention name: Placebo
arm group label: placebo patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Joakim Bischoff
investigator title: MD
mesh term: Capsaicin