<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/NCT02228928</url>
  </required_header>
  <id_info>
    <org_study_id>CAPNP201</org_study_id>
    <nct_id>NCT02228928</nct_id>
  </id_info>
  <brief_title>Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain</brief_title>
  <official_title>Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in the Management of Peripheral Neuropathic Pain ; Early Phase II, Multi-center, Randomized, and Semi-double Blind Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samyang Biopharmaceuticals Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samyang Biopharmaceuticals Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The efficacy and safety of the low concentration [0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)]&#xD;
      capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch&#xD;
      in patients suffering from peripheral neuropathy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</primary_completion_date>
  <phase>Phase 1/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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean difference in the change of daily NRS pain score</measure>
    <time_frame>6 weeks</time_frame>
    <description>Mean numeric change in numerical rating scale pain score from the baseline (Visit 2) to the score at weeks 6 (Visit 5) in each group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with &gt;=30% or &gt;=50% reduction in pain</measure>
    <time_frame>6 weeks</time_frame>
    <description>The percentage of responders (&gt;=30% reduction) and the percentage of patients achieving a &gt;=50% in NRS pain scores were compared among groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Sleep Interference Scale</measure>
    <time_frame>2, 4, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression for Improvement</measure>
    <time_frame>2, 4, 6 weeks</time_frame>
    <description>Clinical Global Impression of Change by the physician and Patient Global Impression of Change by the patients were used to evaluate the subjective perception of decrease in pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>6 weeks</time_frame>
    <description>For EQ-5DTM Health Survey, mean change from the baseline (Visit 2) to the score at weeks 6 (Visit 5) was shown as frequencies and their percentages</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Peripheral Nerve Injury</condition>
  <condition>Postherpetic Neuralgia</condition>
  <arm_group>
    <arm_group_label>CAPNP, 50 ug/cm2 capsaicin patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAPNP, 100 ug/cm2 capsaicin patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100ug/cm2 capsaicin patch, 49cm2, 1patch/4days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.075% capsaicin cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>capsaicin cream qc/day</description>
  </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>CAPNP, 50 ug/cm2 capsaicin patch</intervention_name>
    <arm_group_label>CAPNP, 50 ug/cm2 capsaicin patch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAPNP, 100 ug/cm2 capsaicin patch</intervention_name>
    <arm_group_label>CAPNP, 100 ug/cm2 capsaicin patch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.075% capsaicin cream</intervention_name>
    <arm_group_label>0.075% capsaicin cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo patch</intervention_name>
    <arm_group_label>Placebo patch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are 18 years of age or older aged having chronic peripheral neuropathy&#xD;
             related with a diagnosis of either PHN or DPN&#xD;
&#xD;
          -  patients with chronic peripheral neuropathic pain for more than 3 months with an&#xD;
             11-pointed Numeric Rating Scale (NRS) pain score ≥ 4&#xD;
&#xD;
          -  patients with a diagnosis of PHN were eligible if at least 3 months had elapsed since&#xD;
             shingles vesicle crusting&#xD;
&#xD;
          -  patients with DPN and well controlled diabetes were asked to maintain a stable dose of&#xD;
             oral hypoglycemic or insulin during the study period&#xD;
&#xD;
          -  patients taking concomitant pain medications such as anticonvulsants, antidepressants,&#xD;
             anxiolytics, and opioids including tramadol were required to maintain a stable dose&#xD;
             for at least 4 weeks before the study enrollment&#xD;
&#xD;
          -  any conservative therapies such as TENS, physical therapy, chiropractic, massage,&#xD;
             biofeedback, or yoga were stopped at least 5 weeks before the enrollment&#xD;
&#xD;
          -  women of childbearing age were required to have a negative pregnancy test and were to&#xD;
             be willing to use an effective method of contraception for at least 28 days after the&#xD;
             last exposure to study medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diffusely distributed neuropathic pain resulting from spinal stenosis, postoperative&#xD;
             origin, complex regional pain syndrome, or genetic neurological disease, or&#xD;
             significant pain outside the target area&#xD;
&#xD;
          -  significant pain of an etiology other than PHN or DNP&#xD;
&#xD;
          -  other severe acute or chronic medical or psychiatric condition, or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or with&#xD;
             investigational product administration or may interfere with compliance or the&#xD;
             interpretation of study results andin the judgment of the investigator would make the&#xD;
             subject inappropriate to participate in the study&#xD;
&#xD;
          -  painful PHN areas located on the face or above the scalp hairline&#xD;
&#xD;
          -  an implanted medical device for the treatment of neuropathic pain&#xD;
&#xD;
          -  use of topically applied agents including capsaicin-containing products, a 5%&#xD;
             lidocaine patch or similar products, local anesthetics, or steroids within the past 21&#xD;
             days&#xD;
&#xD;
          -  hypersensitivity known to capsaicin; current use of any class 1 anti-arrhythmic drug;&#xD;
             and uncontrolled diabetes mellitus or uncontrolled hypertension&#xD;
&#xD;
          -  If patients have taken oral NSAID or COX2 Inhibitor, it should be stopped at least2&#xD;
             weeks before randomization; however acetaminophen for pain control was allowed up to&#xD;
             4g per day&#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>Seoul National University Hospital, Seoula National University Bundang Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>April 27, 2017</last_update_submitted>
  <last_update_submitted_qc>April 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peripheral Nerve Injury</keyword>
  <keyword>Postherpetic Neuralgia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Neuralgia, Postherpetic</mesh_term>
    <mesh_term>Peripheral Nerve Injuries</mesh_term>
  </condition_browse>
  <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/NCT02228928
org study id: CAPNP201
nct id: NCT02228928
lead sponsor: 
has dmc: No
The efficacy and safety of the low concentration [0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)]
      capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch
      in patients suffering from peripheral neuropathy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean difference in the change of daily NRS pain score
time frame: 6 weeks
description: Mean numeric change in numerical rating scale pain score from the baseline (Visit 2) to the score at weeks 6 (Visit 5) in each group
measure: Percentage of patients with >=30% or >=50% reduction in pain
time frame: 6 weeks
description: The percentage of responders (>=30% reduction) and the percentage of patients achieving a >=50% in NRS pain scores were compared among groups
measure: Daily Sleep Interference Scale
time frame: 2, 4, 6 weeks
measure: Clinical Global Impression for Improvement
time frame: 2, 4, 6 weeks
description: Clinical Global Impression of Change by the physician and Patient Global Impression of Change by the patients were used to evaluate the subjective perception of decrease in pain intensity
measure: EQ-5D
time frame: 6 weeks
description: For EQ-5DTM Health Survey, mean change from the baseline (Visit 2) to the score at weeks 6 (Visit 5) was shown as frequencies and their percentages
arm group label: CAPNP, 50 ug/cm2 capsaicin patch
arm group type: Experimental
description: 50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days
arm group label: CAPNP, 100 ug/cm2 capsaicin patch
arm group type: Experimental
description: 100ug/cm2 capsaicin patch, 49cm2, 1patch/4days
arm group label: 0.075% capsaicin cream
arm group type: Active Comparator
description: capsaicin cream qc/day
arm group label: Placebo patch
arm group type: Placebo Comparator
intervention type: Drug
intervention name: CAPNP, 50 ug/cm2 capsaicin patch
arm group label: CAPNP, 50 ug/cm2 capsaicin patch
intervention type: Drug
intervention name: CAPNP, 100 ug/cm2 capsaicin patch
arm group label: CAPNP, 100 ug/cm2 capsaicin patch
intervention type: Drug
intervention name: 0.075% capsaicin cream
arm group label: 0.075% capsaicin cream
intervention type: Other
intervention name: Placebo patch
arm group label: Placebo patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Neuralgia, Postherpetic
mesh term: Peripheral Nerve Injuries
mesh term: Capsaicin