<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/NCT02241629</url>
  </required_header>
  <id_info>
    <org_study_id>BOJI-1423Q</org_study_id>
    <nct_id>NCT02241629</nct_id>
  </id_info>
  <brief_title>Levo Phencynonate Hydrochloride for the Prevention of Seasickness</brief_title>
  <official_title>Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sihuan Pharmaceutical Holdings Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sihuan Pharmaceutical Holdings Group Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical&#xD;
      superiority study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety&#xD;
      tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the&#xD;
      impact of voyage experience. 3) On-boat drug testing period. The subjects will be&#xD;
      administered the drug before voyage. The seasickness symptoms will be evaluated during&#xD;
      voyage. The safety test will be conducted before and after one day of on-boat testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the symptoms of seasickness</measure>
    <time_frame>Two hours of voyage</time_frame>
    <description>Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Motion Sickness</condition>
  <arm_group>
    <arm_group_label>levo phencynonate hydrochloride 1mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>levo phencynonate hydrochloride tablet 1mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>levo phencynonate hydrochloride 2mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>levo phencynonate hydrochloride 2mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo of levo phencynonate hydrochloride</description>
    <arm_group_label>levo phencynonate hydrochloride 1mg</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>levo phencynonate hydrochloride</intervention_name>
    <description>levo phencynonate hydrochloride</description>
    <arm_group_label>levo phencynonate hydrochloride 1mg</arm_group_label>
    <arm_group_label>levo phencynonate hydrochloride 2mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects fulfilling the diagnostic criteria for motion sickness&#xD;
&#xD;
          -  Have medical history for motion sickness&#xD;
&#xD;
          -  During screening, the severity of sea sickness is assessed as moderate or above&#xD;
             according to sea sickness severity scale.&#xD;
&#xD;
          -  Adults for 18-55 years, male or female.&#xD;
&#xD;
          -  Agree to participate the study and can sign the ICF independently.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be allergic to the study drug or be allergic constitution&#xD;
&#xD;
          -  ALT, AST≥ 1.5 times of ULN, Scr&gt;ULN, or other clinical significant lab values.&#xD;
&#xD;
          -  Abnormal ECG which is clinical significant judged by investigators, including:&#xD;
             QTc&gt;normal range&#xD;
&#xD;
          -  Have medical history for urination disorder&#xD;
&#xD;
          -  Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion&#xD;
             sickness.&#xD;
&#xD;
          -  Have active gastrointestinal diseases or overweight (BMI≥24kg/m2 )&#xD;
&#xD;
          -  Have internal ear disease which may disturb the evaluation of motion sickness.&#xD;
&#xD;
          -  Have glaucoma or posterior circulation ischemia&#xD;
&#xD;
          -  Have anxiety, depression or other mental disease that investigator considering&#xD;
             inadaptable to participate the study.&#xD;
&#xD;
          -  Participated in other studies within the past 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weiguo Xue</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qingdao Municipal Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qingdao municipal hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>May 6, 2015</last_update_submitted>
  <last_update_submitted_qc>May 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>motion sickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motion Sickness</mesh_term>
  </condition_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/NCT02241629
org study id: BOJI-1423Q
nct id: NCT02241629
lead sponsor: 
has dmc: No
A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical
      superiority study.
The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety
      tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the
      impact of voyage experience. 3) On-boat drug testing period. The subjects will be
      administered the drug before voyage. The seasickness symptoms will be evaluated during
      voyage. The safety test will be conducted before and after one day of on-boat testing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: the symptoms of seasickness
time frame: Two hours of voyage
description: Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.
arm group label: levo phencynonate hydrochloride 1mg
arm group type: Experimental
description: levo phencynonate hydrochloride tablet 1mg
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo
arm group label: levo phencynonate hydrochloride 2mg
arm group type: Experimental
description: levo phencynonate hydrochloride 2mg
intervention type: Drug
intervention name: placebo
description: placebo of levo phencynonate hydrochloride
arm group label: levo phencynonate hydrochloride 1mg
arm group label: placebo
intervention type: Drug
intervention name: levo phencynonate hydrochloride
description: levo phencynonate hydrochloride
arm group label: levo phencynonate hydrochloride 1mg
arm group label: levo phencynonate hydrochloride 2mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Weiguo Xue
role: Principal Investigator
affiliation: Qingdao Municipal Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Motion Sickness