<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/NCT02211898</url>
  </required_header>
  <id_info>
    <org_study_id>1138.6</org_study_id>
    <nct_id>NCT02211898</nct_id>
  </id_info>
  <brief_title>Clinical Study of BNS003 on Swelling in Legs Due to Venous Reflux</brief_title>
  <official_title>Clinical Study of BNS003 on Swelling Due to Disorder of Leg Venous Reflux</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of&#xD;
      heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with&#xD;
      swelling of calf and ankle due to disorder of leg venous reflux.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2004</start_date>
  <primary_completion_date type="Actual">January 2005</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global improvement on a five point scale</measure>
    <time_frame>week 12</time_frame>
    <description>The degree of improvement was evaluated according to change of severity of each symptom at the time of enrollment (baseline) and in Week 12 after initiation of dosing (or at discontinuation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse drug reactions</measure>
    <time_frame>up to week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement per symptom on a five point scale</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in circumference measurements of calf in centimetres</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in circumference measurements of ankle in centimetres</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's impression on improvement on a five point scale</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with of adverse events</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>BNS003</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BNS003</intervention_name>
    <arm_group_label>BNS003</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Manifestation of swelling falling into Class 1 according to Porter's classification&#xD;
&#xD;
          -  With more than 2 symptoms of &quot;sensation of heaviness/tiredness (dullness),&quot; &quot;tension,&quot;&#xD;
             &quot;tingling,&quot; &quot;pain,&quot; &quot;fever&quot; or &quot;itching&quot; and a total score of &gt;=3 for severity by&#xD;
             symptoms&#xD;
&#xD;
          -  Persons aged 20 years or older at the time of obtaining their informed consent and&#xD;
             available for hospital visits. Both genders are acceptable&#xD;
&#xD;
          -  Persons who have consented to participating in the study in written form with good&#xD;
             understanding of the objective of the study, the methods, and notices for the study&#xD;
             period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons with edema not due to venous diseases of the legs (e.g., lymphedema, latent&#xD;
             cardiac or renal insufficiency, etc.)&#xD;
&#xD;
          -  Persons with peripheral arterial diseases&#xD;
&#xD;
          -  Persons with acute phlebitis, venous ulcer, congenital vascular anomaly, or Behcet's&#xD;
             Syndrome&#xD;
&#xD;
          -  Persons with &quot;moderate&quot; or &quot;severe&quot; renal, hepatic, cardiac or haematological&#xD;
             disorder, or with a history of such disorder (Grade 3 or 4 in Common Toxicity Criteria&#xD;
             (CTC))&#xD;
&#xD;
          -  Persons with diabetes mellitus (excluding those curable with dietary therapy),&#xD;
             neuropathy, hyper-or hypocalcemia, or malignant tumors&#xD;
&#xD;
          -  Persons with drug or alcohol abuse&#xD;
&#xD;
          -  Persons with immobility&#xD;
&#xD;
          -  Persons with pulmonary embolism&#xD;
&#xD;
          -  Persons with hypersensitivity to drugs (particularly to the ingredients contained in&#xD;
             the investigational drug)&#xD;
&#xD;
          -  Persons with clinical indication of requiring venous treatment such as physical&#xD;
             application (use of elastic bandage and compression stockings) and phlebectomy (vein&#xD;
             stripping surgery to remove vein affected with varicosis and valve insufficiency)&#xD;
&#xD;
          -  Persons who received venous sclerosing therapy within the last 4 weeks before starting&#xD;
             this study&#xD;
&#xD;
          -  Persons who constantly use theophylline preparations, diuretics, cardiac glycosides&#xD;
&#xD;
          -  Persons who had changed to or initiated post-menopausal hormone replacement therapy&#xD;
             within the last 2 months before starting this study&#xD;
&#xD;
          -  Persons unable to suspend the frequent use and exceeded dosage/administration of&#xD;
             laxatives (more than 6 times) during the study period&#xD;
&#xD;
          -  Persons planned to undergo a surgery requiring systemic anesthesia during the study&#xD;
             period&#xD;
&#xD;
          -  Women in pregnancy or nursing, or those who wish for a pregnancy during the study&#xD;
             period&#xD;
&#xD;
          -  Persons who participated in another study within the last 3 months before starting&#xD;
             this study, or who plan to participate in another study during the study period&#xD;
&#xD;
          -  Persons who were considered to be ineligible to be a subject for the trial by the&#xD;
             investigator or sub-investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</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>Venous Insufficiency</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/NCT02211898
org study id: 1138.6
nct id: NCT02211898
lead sponsor: 
To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of
      heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with
      swelling of calf and ankle due to disorder of leg venous reflux.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Global improvement on a five point scale
time frame: week 12
description: The degree of improvement was evaluated according to change of severity of each symptom at the time of enrollment (baseline) and in Week 12 after initiation of dosing (or at discontinuation)
measure: Number of patients with adverse drug reactions
time frame: up to week 12
measure: Improvement per symptom on a five point scale
time frame: 12 weeks
measure: Change in circumference measurements of calf in centimetres
time frame: baseline, 12 weeks
measure: Change in circumference measurements of ankle in centimetres
time frame: baseline, 12 weeks
measure: Subject's impression on improvement on a five point scale
time frame: baseline, 12 weeks
measure: Number of patients with of adverse events
time frame: up to 12 weeks
arm group label: BNS003
arm group type: Experimental
intervention type: Drug
intervention name: BNS003
arm group label: BNS003
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Venous Insufficiency