<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/NCT03758079</url>
  </required_header>
  <id_info>
    <org_study_id>064-17/717</org_study_id>
    <nct_id>NCT03758079</nct_id>
  </id_info>
  <brief_title>Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus</brief_title>
  <official_title>Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Balamand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Balamand</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single blind randomized trial to compare efficacy and side effects of Gabapentin&#xD;
      with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint&#xD;
      George Hospital University Medical Centre were included in this study. Patients were divided&#xD;
      into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after&#xD;
      each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were&#xD;
      treated reversley. Pruritus severity and its effect on quality of life will be assessed by&#xD;
      using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index&#xD;
      (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2&#xD;
      and week4&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many&#xD;
      options have been used for the management of uremic pruritus (UP) such as Pregabalin,&#xD;
      Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be&#xD;
      effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used&#xD;
      orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic&#xD;
      dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in&#xD;
      hemodialysis patients.&#xD;
&#xD;
      No comparative head to head study between Gabapentin and Doxepine has been conducted to date.&#xD;
      The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus&#xD;
      in hemodialysis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">October 8, 2018</completion_date>
  <primary_completion_date type="Actual">October 8, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4</measure>
    <time_frame>1, 2, 4 weeks</time_frame>
    <description>a 10cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored as follows: no pruritus (VAS score 0), mild (VAS score 1-3) with episodic and localized pruritus without disturbance in usual work and sleep, moderate (VAS score 4-7) with generalized and continuous pruritus without sleep disturbance and severe (VAS score 8-10) with generalized, continuous pruritus and sleep disturbance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in 5-D Itch Scale score at week 4</measure>
    <time_frame>1, 2, 4 weeks</time_frame>
    <description>multidimensional questionnaire. The five dimensions are degree, duration, direction, disability and distribution. The scores of each of the five domains will be achieved separately and then summed together to obtain a total 5-D score ranging between five (no pruritus) and 25 (most severe pruritus). For the distribution domain, the number of affected body parts is tallied (potential sum 0-16) and the sum is sorted into five scoring bins: sum of 0-21⁄4score of 1, sum of 3-51⁄4score of 2, sum of 6-101⁄4score of 3, sum of 11-131⁄4score of 4 and sum of 14-161⁄4score of 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Dermatology life quality index (DLQI) at week 4</measure>
    <time_frame>1, 2, 4 weeks</time_frame>
    <description>10-Item questionnaire evaluating: impact of skin condition on HRQoL during the past week, symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment. A Score range from 0 to 30.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects of each treatment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of patients who report side effects while on each treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Uremic Pruritus</condition>
  <arm_group>
    <arm_group_label>Doxepin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg Doxepin daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gabapentin 100mg after each dialysis session</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxepin</intervention_name>
    <description>10 mg Doxepin for 4 weeks</description>
    <arm_group_label>Doxepin</arm_group_label>
    <other_name>Silenor</other_name>
    <other_name>Sinequan</other_name>
    <other_name>Adapin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <other_name>Neurontin</other_name>
    <other_name>Gralise</other_name>
    <other_name>Gabarone</other_name>
    <other_name>Fanatrex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  prevalent patients undergoing HD with UP for at least three months&#xD;
&#xD;
          -  any medications with antipruritic effects to be discontinued one week before the study&#xD;
&#xD;
          -  Hemodialysis performed for 3-4 h thrice weekly via a low flux polysulphonedialyser&#xD;
             [1.3-1.6 m2 surface areas] using bicarbonate and/or acetate dialysis fluid&#xD;
&#xD;
          -  well controlled Calcium, Phosphorus and iPTH levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients labeled high risk of fall (Having a score more than 16/20 using part 1 from&#xD;
             Falls Risk Assessment Tool (FRAT)&#xD;
&#xD;
          -  patients taking drugs that interact with doxepin or gabapentin&#xD;
&#xD;
          -  patients with hepatic failure&#xD;
&#xD;
          -  patients with hyperthyroidism&#xD;
&#xD;
          -  patients with narrow angle glaucoma&#xD;
&#xD;
          -  patients with heart block or decompensated heart failure or hypotension (defined as&#xD;
             systolic blood pressure less than 90 mmHg) or myocardial infarction in the past three&#xD;
             months&#xD;
&#xD;
          -  history of allergy to gabapentin or doxepin&#xD;
&#xD;
          -  uncontrolled psychiatric diseases&#xD;
&#xD;
          -  pregnant patients&#xD;
&#xD;
          -  patients with psoriasis, atopic dermatitis or any other condition that can justify the&#xD;
             pruritus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger N Haber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Balamand/Saint George Hospital University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint George Hospital University Medical Center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Balamand</investigator_affiliation>
    <investigator_full_name>Julien Bachour, MD</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Doxepin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03758079
org study id: 064-17/717
nct id: NCT03758079
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a single blind randomized trial to compare efficacy and side effects of Gabapentin
      with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint
      George Hospital University Medical Centre were included in this study. Patients were divided
      into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after
      each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were
      treated reversley. Pruritus severity and its effect on quality of life will be assessed by
      using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index
      (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2
      and week4
Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many
      options have been used for the management of uremic pruritus (UP) such as Pregabalin,
      Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be
      effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used
      orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic
      dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in
      hemodialysis patients.

      No comparative head to head study between Gabapentin and Doxepine has been conducted to date.
      The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus
      in hemodialysis patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4
time frame: 1, 2, 4 weeks
description: a 10cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored as follows: no pruritus (VAS score 0), mild (VAS score 1-3) with episodic and localized pruritus without disturbance in usual work and sleep, moderate (VAS score 4-7) with generalized and continuous pruritus without sleep disturbance and severe (VAS score 8-10) with generalized, continuous pruritus and sleep disturbance.
measure: Change from baseline in 5-D Itch Scale score at week 4
time frame: 1, 2, 4 weeks
description: multidimensional questionnaire. The five dimensions are degree, duration, direction, disability and distribution. The scores of each of the five domains will be achieved separately and then summed together to obtain a total 5-D score ranging between five (no pruritus) and 25 (most severe pruritus). For the distribution domain, the number of affected body parts is tallied (potential sum 0-16) and the sum is sorted into five scoring bins: sum of 0-21⁄4score of 1, sum of 3-51⁄4score of 2, sum of 6-101⁄4score of 3, sum of 11-131⁄4score of 4 and sum of 14-161⁄4score of 5
measure: Change from baseline in Dermatology life quality index (DLQI) at week 4
time frame: 1, 2, 4 weeks
description: 10-Item questionnaire evaluating: impact of skin condition on HRQoL during the past week, symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment. A Score range from 0 to 30.
measure: side effects of each treatment
time frame: 4 weeks
description: Number of patients who report side effects while on each treatment
arm group label: Doxepin
arm group type: Active Comparator
description: 10 mg Doxepin daily for 4 weeks
arm group label: Gabapentin
arm group type: Active Comparator
description: Gabapentin 100mg after each dialysis session
intervention type: Drug
intervention name: Doxepin
description: 10 mg Doxepin for 4 weeks
arm group label: Doxepin
other name: Silenor
other name: Sinequan
other name: Adapin
intervention type: Drug
intervention name: Gabapentin
description: dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
arm group label: Gabapentin
other name: Neurontin
other name: Gralise
other name: Gabarone
other name: Fanatrex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Roger N Haber, MD
role: Principal Investigator
affiliation: University of Balamand/Saint George Hospital University Medical Center
facility: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: University of Balamand
investigator full name: Julien Bachour, MD
investigator title: Principle Investigator
mesh term: Pruritus
mesh term: Gabapentin
mesh term: Doxepin
sharing ipd: Undecided