<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/NCT03808805</url>
  </required_header>
  <id_info>
    <org_study_id>ApHyPAP 29BRC18.0036</org_study_id>
    <nct_id>NCT03808805</nct_id>
  </id_info>
  <brief_title>Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms</brief_title>
  <acronym>APHYPAP</acronym>
  <official_title>Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.</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>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>
      Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies&#xD;
      APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and&#xD;
      suffering of persistent aquagenic pruritus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Identification of patients with myeloproliferative neoplasms and aquagenic pruritus.&#xD;
      Evaluation of the intensity of the aquagenic pruritus. Patients with value &gt;5/10 on the VAS&#xD;
      (Visual Analogue Scale ) are proposed to participate to the protocole. Randomization between&#xD;
      the two treatments. Duration of the treatment : 14 days. Regular evaluation of efficacity of&#xD;
      the drugs (questionnaires). Evaluations will stop 2 months after the last intake. Blood&#xD;
      samples will be collected before and after the intakes to study cytokine and neuropeptide&#xD;
      levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2021</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>
    <intervention_model_description>Phase 3, randomized prospective study, double blind-double placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )</measure>
    <time_frame>at 15 days</time_frame>
    <description>number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )</measure>
    <time_frame>at 60 days</time_frame>
    <description>number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cessation of pruritus</measure>
    <time_frame>at 15 days</time_frame>
    <description>number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms) )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cessation of pruritus</measure>
    <time_frame>at 60 days</time_frame>
    <description>number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time observed to decreased the VAS to 3/10</measure>
    <time_frame>01 to 60 days</time_frame>
    <description>number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of treatment effectiveness</measure>
    <time_frame>1 to 60 days</time_frame>
    <description>number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event occurring during the association therapeutic</measure>
    <time_frame>at 15 days</time_frame>
    <description>type of adverse event occuring during the treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of prematurely discontinued anti-pruritic treatment</measure>
    <time_frame>at 15 days</time_frame>
    <description>Total number of prematurely discontinued treatments for all subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete blood count (normal or abnormal)</measure>
    <time_frame>1 to 60 days</time_frame>
    <description>number of patients with hematologic remission : hematocrit &lt;45% with leukocytes &lt;10 giga/l and platelets &lt;400 giga/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire</measure>
    <time_frame>at J0 (day of inclusion)</time_frame>
    <description>Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire</measure>
    <time_frame>at J0 (day of inclusion)</time_frame>
    <description>Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire</measure>
    <time_frame>at 15 days</time_frame>
    <description>Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers)questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire</measure>
    <time_frame>at 15 days</time_frame>
    <description>Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire</measure>
    <time_frame>at 30 days</time_frame>
    <description>Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire</measure>
    <time_frame>at 30 days</time_frame>
    <description>Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire</measure>
    <time_frame>at 45 days</time_frame>
    <description>Evaluation of quality of life by completion of the MPN-SAF(Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire</measure>
    <time_frame>at 45 days</time_frame>
    <description>Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire</measure>
    <time_frame>at 60 days</time_frame>
    <description>Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire</measure>
    <time_frame>at 60 days</time_frame>
    <description>Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of the change of plasma concentrations of cytokines and neuropeptides</measure>
    <time_frame>at J0 (day of inclusion)</time_frame>
    <description>Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of the change of plasma concentrations of cytokines and neuropeptides</measure>
    <time_frame>at 15 days</time_frame>
    <description>Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of the change of plasma concentrations of cytokines and neuropeptides</measure>
    <time_frame>at 30 days</time_frame>
    <description>Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of the change of plasma concentrations of cytokines and neuropeptides</measure>
    <time_frame>at 60 days</time_frame>
    <description>Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Myeloproliferative Disorder</condition>
  <condition>Aquagenic Pruritus</condition>
  <arm_group>
    <arm_group_label>studied group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>comparative group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aprepitant 80 mg</intervention_name>
    <description>oral therapy - daily dose - 14 days</description>
    <arm_group_label>studied group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxyzine 25mg</intervention_name>
    <description>oral therapy - daily dose - 14 days</description>
    <arm_group_label>comparative group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo of Hydroxyzine</intervention_name>
    <description>oral therapy - daily dose - 14 days</description>
    <arm_group_label>studied group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo of Aprepitant</intervention_name>
    <description>oral therapy - daily dose - 14 days</description>
    <arm_group_label>comparative group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients with myeloproliferative neoplasms (polycythemia vera, essential&#xD;
             thrombocythaemia or myelofibrosis)&#xD;
&#xD;
          -  and treated with hydroxyurea, pipobroman, anagrelide, α2a pegylated interferon,&#xD;
             ruxolitinib or bled for more than 6 months&#xD;
&#xD;
          -  and suffering of persistent aquagenic pruritus&#xD;
&#xD;
          -  and with a pruritus intensity on Analogic Visual Scale &gt;5/10&#xD;
&#xD;
          -  patients who gave their written consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a physical or psychological disability to sign the consent form&#xD;
&#xD;
          -  patients with myeloproliferative neoplasms and suffering of aquagenic pruritus but&#xD;
             only treated by aspirin&#xD;
&#xD;
          -  patients already included in another therapeutic protocol&#xD;
&#xD;
          -  patients with diffuse dermatological disease where pruritus may be present (psoriasis,&#xD;
             atopic dermatitis, prurigo&#xD;
&#xD;
          -  patients already on anti-anxiety and / or anti-depressant treatment&#xD;
&#xD;
          -  patients with absolute contraindications to the use of Aprepitant or Hydroxyzine&#xD;
&#xD;
          -  hypersensitivity to Aprepitant and / or Hydroxyzine or to any of their excipients&#xD;
&#xD;
          -  lactose intolerance&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Christophe IANOTTO, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hématologie Clinique-Institut de Cancéro-Hématologie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Christophe IANOTTO, MD, PhD</last_name>
    <phone>02 98 22 37 86</phone>
    <phone_ext>+33</phone_ext>
    <email>jean-christophe.ianotto@chu-brest.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU de Brest - Hôpital Morvan</name>
      <address>
        <city>Brest</city>
        <state>Brest Cedex</state>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Christophe IANOTTO, Pr</last_name>
      <phone>02 98 22 37 86</phone>
      <email>jean-christophe.ianotto@chu-brest.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Françoise BOYER, Dr</last_name>
      <phone>02 41 35 54 50</phone>
      <email>FrBoyer-Perrard@chu-angers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gandhi Laurent DAMAJ, Pr</last_name>
      <phone>0231272140</phone>
      <email>damaj-gl@chu-caen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Douarnenez</name>
      <address>
        <city>Douarnenez</city>
        <zip>29171</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne-Sophie LE BRIS-MICHEL, Dr</last_name>
      <phone>02 98 75 15 85</phone>
      <email>as.lebris@ch-douarnenez.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frédéric GARBAN, Pr</last_name>
      <phone>0476765661</phone>
      <email>FGarban@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck NICOLINI, Dr</last_name>
      <phone>0469856193</phone>
      <email>Franck-Emmanuel.NICOLINI@lyon.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier des Pays de Morlaix</name>
      <address>
        <city>Morlaix</city>
        <zip>29672</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mohamed MALOU, Pr</last_name>
      <phone>02 98 62 60 38</phone>
      <email>mmalou@ch-morlaix.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Viviane DUBRUILLE, Dr</last_name>
      <phone>02 40 08 32 81</phone>
      <email>viviane.dubruille@chu-nantes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Cornouaille</name>
      <address>
        <city>Quimper</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal HUTIN, Dr</last_name>
      <phone>02 98 52 61 50</phone>
      <phone_ext>+33</phone_ext>
      <email>p.hutin@ch-cornouaille.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc BERNARD, Dr</last_name>
      <phone>0299284292</phone>
      <email>marc.bernard@chu-rennes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Yves Le Foll</name>
      <address>
        <city>Saint-Brieuc</city>
        <zip>22027</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Iuliana MARTINIUC</last_name>
      <phone>02 96 01 75 87</phone>
      <email>iuliana.martiniuc@ch-stbrieuc.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myeloproliferative Disorders</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aprepitant</mesh_term>
    <mesh_term>Fosaprepitant</mesh_term>
    <mesh_term>Hydroxyzine</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/NCT03808805
org study id: ApHyPAP 29BRC18.0036
nct id: NCT03808805
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies
      APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and
      suffering of persistent aquagenic pruritus.
Identification of patients with myeloproliferative neoplasms and aquagenic pruritus.
      Evaluation of the intensity of the aquagenic pruritus. Patients with value >5/10 on the VAS
      (Visual Analogue Scale ) are proposed to participate to the protocole. Randomization between
      the two treatments. Duration of the treatment : 14 days. Regular evaluation of efficacity of
      the drugs (questionnaires). Evaluations will stop 2 months after the last intake. Blood
      samples will be collected before and after the intakes to study cytokine and neuropeptide
      levels.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Phase 3, randomized prospective study, double blind-double placebo
primary purpose: Treatment
masking: Single (Participant)
measure: Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
time frame: at 15 days
description: number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)
measure: Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
time frame: at 60 days
description: number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)
measure: Cessation of pruritus
time frame: at 15 days
description: number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms) )
measure: Cessation of pruritus
time frame: at 60 days
description: number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms))
measure: Time observed to decreased the VAS to 3/10
time frame: 01 to 60 days
description: number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )
measure: Duration of treatment effectiveness
time frame: 1 to 60 days
description: number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10
measure: Adverse event occurring during the association therapeutic
time frame: at 15 days
description: type of adverse event occuring during the treatment period
measure: Number of prematurely discontinued anti-pruritic treatment
time frame: at 15 days
description: Total number of prematurely discontinued treatments for all subjects
measure: Complete blood count (normal or abnormal)
time frame: 1 to 60 days
description: number of patients with hematologic remission : hematocrit <45% with leukocytes <10 giga/l and platelets <400 giga/l
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
time frame: at J0 (day of inclusion)
description: Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
time frame: at J0 (day of inclusion)
description: Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
time frame: at 15 days
description: Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers)questionnaire
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
time frame: at 15 days
description: Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
measure: Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
time frame: at 30 days
description: Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
time frame: at 30 days
description: Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
time frame: at 45 days
description: Evaluation of quality of life by completion of the MPN-SAF(Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
time frame: at 45 days
description: Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
time frame: at 60 days
description: Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
time frame: at 60 days
description: Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
time frame: at J0 (day of inclusion)
description: Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
time frame: at 15 days
description: Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
time frame: at 30 days
description: Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
time frame: at 60 days
description: Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
arm group label: studied group
arm group type: Experimental
description: Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
arm group label: comparative group
arm group type: Active Comparator
description: Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days
intervention type: Drug
intervention name: Aprepitant 80 mg
description: oral therapy - daily dose - 14 days
arm group label: studied group
intervention type: Drug
intervention name: Hydroxyzine 25mg
description: oral therapy - daily dose - 14 days
arm group label: comparative group
intervention type: Drug
intervention name: Placebo of Hydroxyzine
description: oral therapy - daily dose - 14 days
arm group label: studied group
intervention type: Drug
intervention name: Placebo of Aprepitant
description: oral therapy - daily dose - 14 days
arm group label: comparative group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Christophe IANOTTO, MD, PhD
role: Principal Investigator
affiliation: Hématologie Clinique-Institut de Cancéro-Hématologie
last name: Jean-Christophe IANOTTO, MD, PhD
phone: 02 98 22 37 86
phone ext: +33
email: jean-christophe.ianotto@chu-brest.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Myeloproliferative Disorders
mesh term: Pruritus
mesh term: Aprepitant
mesh term: Fosaprepitant
mesh term: Hydroxyzine