<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/NCT02264535</url>
  </required_header>
  <id_info>
    <org_study_id>Z-YXPU-ZS-IV4</org_study_id>
    <nct_id>NCT02264535</nct_id>
  </id_info>
  <brief_title>A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.</brief_title>
  <official_title>A Pilot Study for Ginkgolides Meglumine Injection Skin Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Kanion Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Bionovo Medicine Development Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jiangsu Kanion Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study is designed to explore the optimal concentration and method of Ginkgolides&#xD;
      Meglumine Injection skin testing and to evaluate the value of skin test in predicting any&#xD;
      possible allergic reactions to Ginkgolides Meglumine Injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be enrolled in one of three groups with different doses to receive skin prick&#xD;
      testing. Then they may be arranged to receive intradermal, subcutaneous injection or&#xD;
      intravenous tests with different doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.</measure>
    <time_frame>15-20 minutes after skin prick tests.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection.</measure>
    <time_frame>15-20 minutes after intradermal tests.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The specificity and sensitivity with the different doses.</measure>
    <time_frame>15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test.</time_frame>
    <description>Specificity (SPC) =TN/ (FP+TN); Sensitivity=TP/ (TP+FN). TP (true positive); TN (true negative); FP (false positive); FN (false negative). TP(true positive); TN(true negative); FP(false positive); FN(false negative).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests.</measure>
    <time_frame>within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it.</time_frame>
    <description>Only the participants who are allergic to the main components of Ginkgolides Meglumine Injection will be assessed in 3-10 days after using it by the investigators..</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>0.1mg/ml Ginkgolides Meglumine Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection, 0.1mg/ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1mg/ml Ginkgolides Meglumine Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection, 1mg/ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5mg/ml Ginkgolides Meglumine Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection, 5mg/ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.1mg/ml Ginkgolides Meglumine Injection</intervention_name>
    <arm_group_label>0.1mg/ml Ginkgolides Meglumine Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1mg/ml Ginkgolides Meglumine Injection</intervention_name>
    <arm_group_label>1mg/ml Ginkgolides Meglumine Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5mg/ml Ginkgolides Meglumine Injection</intervention_name>
    <arm_group_label>5mg/ml Ginkgolides Meglumine Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female between the ages of 18 and 70(inclusive)at the time of signing the&#xD;
             Informed Consent Form （ICF）.&#xD;
&#xD;
          -  Subjects meet any one of the following requirements&#xD;
&#xD;
               -  No history of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B,&#xD;
                  Ginkgolide K (including Ginkgolides Meglumine Injection).&#xD;
&#xD;
               -  History of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B,&#xD;
                  Ginkgolide K (including Ginkgolides Meglumine Injection), and no allergy.&#xD;
&#xD;
               -  History of allergy to any dugs contain bilobalide, Ginkgolide A, Ginkgolide B,&#xD;
                  Ginkgolide K (including Ginkgolides Meglumine Injection).&#xD;
&#xD;
               -  History of allergy to any other drugs.&#xD;
&#xD;
          -  Willingness to participate in the study as evidenced by signing the informed consent&#xD;
             form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women in breastfeeding,menstrual or pregnancy period.&#xD;
&#xD;
          -  Subjects are in the infectious disease, eczema, dermatitis, trauma,etc.&#xD;
&#xD;
          -  Subjects meet any one of the following conditions&#xD;
&#xD;
               -  Used β-blockers within 2 days prior to starting this study.&#xD;
&#xD;
               -  Used H1 anti-histamines, imipramine, phenothiazine, Beta adrenaline etc. within 1&#xD;
                  week prior to starting this study.&#xD;
&#xD;
               -  Used short-acting glucocorticoids drugs within 1 week prior to starting this&#xD;
                  study.&#xD;
&#xD;
               -  Topical used glucocorticoids drugs within 2 weeks prior to starting this study.&#xD;
&#xD;
               -  Used long-acting glucocorticoids drugs within 4 weeks prior to starting this&#xD;
                  study&#xD;
&#xD;
          -  Subjects are currently participating or have participated in any other clinical trials&#xD;
             within the prior 1 month of signing the ICF.&#xD;
&#xD;
          -  Subjects have a history of allergic shock.&#xD;
&#xD;
          -  Subjects who are not suitable for this clinical trial at the discretion of the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuhong Huang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital of Tianjin University of TCM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <zip>300150</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>November 26, 2014</last_update_submitted>
  <last_update_submitted_qc>November 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergy</keyword>
  <keyword>Skin test</keyword>
  <keyword>Ginkgolides Meglumine Injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</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/NCT02264535
org study id: Z-YXPU-ZS-IV4
nct id: NCT02264535
lead sponsor: 
collaborator: 
has dmc: No
This pilot study is designed to explore the optimal concentration and method of Ginkgolides
      Meglumine Injection skin testing and to evaluate the value of skin test in predicting any
      possible allergic reactions to Ginkgolides Meglumine Injection.
Subjects will be enrolled in one of three groups with different doses to receive skin prick
      testing. Then they may be arranged to receive intradermal, subcutaneous injection or
      intravenous tests with different doses.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.
time frame: 15-20 minutes after skin prick tests.
measure: The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection.
time frame: 15-20 minutes after intradermal tests.
measure: The specificity and sensitivity with the different doses.
time frame: 15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test.
description: Specificity (SPC) =TN/ (FP+TN); Sensitivity=TP/ (TP+FN). TP (true positive); TN (true negative); FP (false positive); FN (false negative). TP(true positive); TN(true negative); FP(false positive); FN(false negative).
measure: Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests.
time frame: within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it.
description: Only the participants who are allergic to the main components of Ginkgolides Meglumine Injection will be assessed in 3-10 days after using it by the investigators..
arm group label: 0.1mg/ml Ginkgolides Meglumine Injection
arm group type: Experimental
description: Injection, 0.1mg/ml.
arm group label: 1mg/ml Ginkgolides Meglumine Injection
arm group type: Experimental
description: Injection, 1mg/ml.
arm group label: 5mg/ml Ginkgolides Meglumine Injection
arm group type: Experimental
description: Injection, 5mg/ml.
intervention type: Drug
intervention name: 0.1mg/ml Ginkgolides Meglumine Injection
arm group label: 0.1mg/ml Ginkgolides Meglumine Injection
intervention type: Drug
intervention name: 1mg/ml Ginkgolides Meglumine Injection
arm group label: 1mg/ml Ginkgolides Meglumine Injection
intervention type: Drug
intervention name: 5mg/ml Ginkgolides Meglumine Injection
arm group label: 5mg/ml Ginkgolides Meglumine Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuhong Huang
role: Principal Investigator
affiliation: Second Affiliated Hospital of Tianjin University of TCM
facility: 
country: China
responsible party type: Sponsor
mesh term: Hypersensitivity