<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/NCT03809702</url>
  </required_header>
  <id_info>
    <org_study_id>BPKoirala</org_study_id>
    <nct_id>NCT03809702</nct_id>
  </id_info>
  <brief_title>Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia</brief_title>
  <official_title>Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B.P. Koirala Institute of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Grants Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>B.P. Koirala Institute of Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the&#xD;
      treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other&#xD;
      routine treatment. Whereas, group 2 will be the control group receiving all routine treatment&#xD;
      similar to group 1 except Pregabalin. Instead control group will receive Placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study wants to see the role of Pregabalin in acute herpetic neuralgia pain reduction and&#xD;
      for the prevention of post herpetic neuralgia incidence as compared to placebo group. For&#xD;
      this purpose, all eligible Herpes Zoster patients will be randomized into two groups (41&#xD;
      patients in each group i.e.82 total patients). Group 1 will be the treatment group receiving&#xD;
      Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas,&#xD;
      group 2 will be the control group receiving all routine treatment similar to group 1 except&#xD;
      Pregabalin. Instead of pregabalin, control group will receive Placebo. The pain will be&#xD;
      evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly&#xD;
      follow up for next three months). If it is difficult for the patient to present physically,&#xD;
      telephonic follow up will be done to find the pain score in the required time. Also, DLQI&#xD;
      (Dermatological life quality index) will be assessed at the first and last visit of the&#xD;
      patient.&#xD;
&#xD;
      At the end, pain score will be compared between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 20, 2019</primary_completion_date>
  <phase>Phase 4</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>Double blinded randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group</measure>
    <time_frame>Eight months</time_frame>
    <description>Percentage reduction of visual analogue scale (VAS) of pain in each follow up visits in intervention group as compared to the placebo group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevention of Post Herpetic Neuralgia</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of post herpetic neuralgia in pregabalin group and placebo group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Herpes Zoster</condition>
  <arm_group>
    <arm_group_label>Pregabalin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 1: Pregabalin tablet 75 mg orally twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment Here, the intervention is administration of Pregabalin tablet 75 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)</description>
    <arm_group_label>Pregabalin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of HZ presenting within 72 hours of onset of rash,&#xD;
&#xD;
          -  With pain score 40 or above on 100 mm pain Visual Analogue Scale at the screening&#xD;
             visit,&#xD;
&#xD;
          -  Giving written consent for the study.&#xD;
&#xD;
          -  Age between 18-70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HZ presenting after 72 hours of onset&#xD;
&#xD;
          -  Pain score less than 40 at baseline&#xD;
&#xD;
          -  Who took the stable doses of oral analgesics like: NSAIDs, acetaminophen, opioids and&#xD;
             antidepressant within six hours of screening visit&#xD;
&#xD;
          -  Using Pregabalin and Gabapentin within last 72 hours&#xD;
&#xD;
          -  Nerve block therapy within the last 48 hours&#xD;
&#xD;
          -  History of hypersensitivity to the drug or its ingredients&#xD;
&#xD;
          -  Use of topical medications within 12 hours&#xD;
&#xD;
          -  Unable to come for follow up because of severe systemic illness&#xD;
&#xD;
          -  Significant hepatic and renal disease,&#xD;
&#xD;
          -  Bed ridden patients or those who are physically unfit for follow up visits.&#xD;
&#xD;
          -  Ethically considered vulnerable members- pregnant/lactating mothers/newborn/children&#xD;
             below 12 years /physically or mentally challenged individuals/HIV/ AIDS/IV drug users&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suchana Marahatta, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>B.P. Koirala Institute of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>B P Koirala Institute of Health Sciences</name>
      <address>
        <city>Dharān Bāzār</city>
        <state>Province 1</state>
        <zip>7053</zip>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>B.P. Koirala Institute of Health Sciences</investigator_affiliation>
    <investigator_full_name>Dr Suchana Marahatta</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Herpes Zoster</keyword>
  <keyword>Herpetic neuralgia</keyword>
  <keyword>Pregabalin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Zoster</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</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/NCT03809702
org study id: BPKoirala
nct id: NCT03809702
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the
      treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other
      routine treatment. Whereas, group 2 will be the control group receiving all routine treatment
      similar to group 1 except Pregabalin. Instead control group will receive Placebo.
This study wants to see the role of Pregabalin in acute herpetic neuralgia pain reduction and
      for the prevention of post herpetic neuralgia incidence as compared to placebo group. For
      this purpose, all eligible Herpes Zoster patients will be randomized into two groups (41
      patients in each group i.e.82 total patients). Group 1 will be the treatment group receiving
      Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas,
      group 2 will be the control group receiving all routine treatment similar to group 1 except
      Pregabalin. Instead of pregabalin, control group will receive Placebo. The pain will be
      evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly
      follow up for next three months). If it is difficult for the patient to present physically,
      telephonic follow up will be done to find the pain score in the required time. Also, DLQI
      (Dermatological life quality index) will be assessed at the first and last visit of the
      patient.

      At the end, pain score will be compared between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blinded randomized controlled trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group
time frame: Eight months
description: Percentage reduction of visual analogue scale (VAS) of pain in each follow up visits in intervention group as compared to the placebo group
measure: Prevention of Post Herpetic Neuralgia
time frame: 12 months
description: Incidence of post herpetic neuralgia in pregabalin group and placebo group
arm group label: Pregabalin group
arm group type: Active Comparator
description: Group 1: Pregabalin tablet 75 mg orally twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment Here, the intervention is administration of Pregabalin tablet 75 mg
arm group label: Placebo group
arm group type: Placebo Comparator
description: Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment
intervention type: Drug
intervention name: Pregabalin
description: Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
arm group label: Pregabalin group
intervention type: Drug
intervention name: Placebo
description: Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Suchana Marahatta, MBBS, MD
role: Principal Investigator
affiliation: B.P. Koirala Institute of Health Sciences
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: B.P. Koirala Institute of Health Sciences
investigator full name: Dr Suchana Marahatta
investigator title: Associate Professor
mesh term: Herpes Zoster
mesh term: Neuralgia
mesh term: Pregabalin