<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/NCT01675986</url>
  </required_header>
  <id_info>
    <org_study_id>GABAPAC</org_study_id>
    <nct_id>NCT01675986</nct_id>
  </id_info>
  <brief_title>Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <brief_summary>
    <textblock>
      The insertion of long-lasting intravenous device is done under local anesthesia. Currently,&#xD;
      in the investigators hospital, no premedication is given to the patients. However, this&#xD;
      procedure occurs in a particular emotional context related to the diagnosis of cancer or&#xD;
      malign hemopathies.&#xD;
&#xD;
      Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure&#xD;
      can be questionable.&#xD;
&#xD;
      Hydroxyzine is the reference molecule for premedication because of its anxiolytic and&#xD;
      anti-histaminic properties A new agent, pregabalin, shares also the same properties&#xD;
&#xD;
      The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on&#xD;
      the anxiety score as a premedication during the insertion of long-lasting intravenous device&#xD;
      under local anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Efficacy treatment</measure>
    <description>anxiety score VAS: 0 to 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of pregabaldin</measure>
    <description>anxiety score VAS:0 to 100</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">306</enrollment>
  <condition>Feeling Anxious</condition>
  <arm_group>
    <arm_group_label>Pregabaline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groups PREGABALINE : 150 mg de LYRICA®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydroxyzine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groups HYDROXYZINE : 75 mg d'ATARAX®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lactose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Groups placebo : 4 g de lactose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hydroxyzine</intervention_name>
    <description>75 mg</description>
    <arm_group_label>Hydroxyzine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>150 mg</description>
    <arm_group_label>Pregabaline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactose</intervention_name>
    <description>4 g</description>
    <arm_group_label>Lactose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 18 to 75 years&#xD;
&#xD;
          -  Patient schedules for insertion of long-lasting intravenous device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous insertion of long-lasting intravenous device or central&#xD;
             intravenous catheter&#xD;
&#xD;
          -  long term treatment of gabapentin or pregabalin&#xD;
&#xD;
          -  Hypersensitivity to pregabalin or any of the excipients&#xD;
&#xD;
          -  Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients,&#xD;
             another derivative of piperazine, aminophylline or ethylene diamine.&#xD;
&#xD;
          -  Patient at risk of glaucoma e&#xD;
&#xD;
          -  Patient at risk for urinary retention&#xD;
&#xD;
          -  Patient severe respiratory failure&#xD;
&#xD;
          -  Patient at the general condition not too corrupted (ASA IV)&#xD;
&#xD;
          -  Renal failure with creatinin clearance &lt; 30 ml / min&#xD;
&#xD;
          -  Patient not affiliated to Social Security&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Patients in emergency situations&#xD;
&#xD;
          -  Inpatient without consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bertrand DEBAENE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Poitiers University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de POITIERS</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>February 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>October 10, 2016</last_update_submitted>
  <last_update_submitted_qc>October 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</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/NCT01675986
org study id: GABAPAC
nct id: NCT01675986
lead sponsor: 
The insertion of long-lasting intravenous device is done under local anesthesia. Currently,
      in the investigators hospital, no premedication is given to the patients. However, this
      procedure occurs in a particular emotional context related to the diagnosis of cancer or
      malign hemopathies.

      Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure
      can be questionable.

      Hydroxyzine is the reference molecule for premedication because of its anxiolytic and
      anti-histaminic properties A new agent, pregabalin, shares also the same properties

      The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on
      the anxiety score as a premedication during the insertion of long-lasting intravenous device
      under local anesthesia.
measure: Efficacy treatment
description: anxiety score VAS: 0 to 100
measure: Efficacy of pregabaldin
description: anxiety score VAS:0 to 100
arm group label: Pregabaline
arm group type: Experimental
description: Groups PREGABALINE : 150 mg de LYRICA®
arm group label: Hydroxyzine
arm group type: Experimental
description: Groups HYDROXYZINE : 75 mg d'ATARAX®
arm group label: Lactose
arm group type: Placebo Comparator
description: Groups placebo : 4 g de lactose
intervention type: Drug
intervention name: hydroxyzine
description: 75 mg
arm group label: Hydroxyzine
intervention type: Drug
intervention name: Pregabalin
description: 150 mg
arm group label: Pregabaline
intervention type: Drug
intervention name: Lactose
description: 4 g
arm group label: Lactose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bertrand DEBAENE, MD
role: Principal Investigator
affiliation: Poitiers University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Pregabalin
mesh term: Hydroxyzine