<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/NCT02191163</url>
  </required_header>
  <id_info>
    <org_study_id>1138.3</org_study_id>
    <nct_id>NCT02191163</nct_id>
  </id_info>
  <brief_title>Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency</brief_title>
  <official_title>A 17 Week, Randomised, Double-blind, Placebo Controlled Cross-over Trial to Evaluate the Efficacy of Antistax® Film Coated Tablets (Extr. Vitis Vinifera Siccum), 360 mg/Day p.o. in Improving Microcirculation of the Skin in the Leg of Male and Female Patients Suffering From Chronic Venous Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the efficacy and safety of Antistax® film coated tablets in improving&#xD;
      microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2002</start_date>
  <primary_completion_date type="Actual">August 2002</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in the resting flux</measure>
    <time_frame>Baseline, after 6 weeks of treatment</time_frame>
    <description>measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in the resting flux</measure>
    <time_frame>Baseline, after 3 weeks of treatment</time_frame>
    <description>measured in the frequency range 10-37 kHz</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the resting flux</measure>
    <time_frame>Baseline, after 3 and 6 weeks of treatment</time_frame>
    <description>measured in the frequency range &lt;10 kHz</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the combined resting fluxes (&lt;37 kHz)</measure>
    <time_frame>Baseline, after 3 and 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the transcutaneous oximetry (TcPO2)</measure>
    <time_frame>Baseline, after 3 and 6 weeks of treatment</time_frame>
    <description>measured on the inside lower leg of the more CVI-affected leg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the calf circumference of the most affected leg</measure>
    <time_frame>Baseline, after 3 and 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the ankle circumference of the most affected leg</measure>
    <time_frame>Baseline, after 3 and 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)</measure>
    <time_frame>Baseline, after 3 and 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)</measure>
    <time_frame>after 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global efficacy assessment by investigator on a 4-point VRS</measure>
    <time_frame>after 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in laboratory values</measure>
    <time_frame>Baseline, up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>Baseline, up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global tolerability assessment by investigator on a 4-point VRS</measure>
    <time_frame>after 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global tolerability assessment by patient on a 4-point VRS</measure>
    <time_frame>after 6 weeks of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>Antistax®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 x 360 mg for 42 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antistax®</intervention_name>
    <arm_group_label>Antistax®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  &gt;= 18 years of age&#xD;
&#xD;
          -  CVI I or CVI II (without expanded trophic disturbances)&#xD;
&#xD;
          -  Willing and able to give written informed consent in accordance to Good Clinical&#xD;
             Practice and local legislation prior to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Concomitant disease(s) exclusion criteria:&#xD;
&#xD;
          -  Decompensated cardiac insufficiency&#xD;
&#xD;
          -  Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal&#xD;
             insufficiency, lymph edema, etc)&#xD;
&#xD;
          -  Peripheral arterial disease (ankle/arm pressure index &lt; 0.9)&#xD;
&#xD;
          -  Current acute phlebitis or thrombosis&#xD;
&#xD;
          -  Renal insufficiency (Serum creatinine &gt; 1.5 mg/dl)&#xD;
&#xD;
          -  Liver disease (SGPT (ALAT) &gt; 3x upper limit of normal)&#xD;
&#xD;
          -  Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or&#xD;
             hypocalcaemia, malignancies&#xD;
&#xD;
          -  Anamnestic indications of diabetic microangiopathy or polyneuropathy&#xD;
&#xD;
          -  Drug and/or alcohol abuse&#xD;
&#xD;
          -  Pregnant or nursing women or inadequate birth control methods (this applies to females&#xD;
             of childbearing potential only)&#xD;
&#xD;
          -  Severe climacteric complaints or changes in, or initiation with post-menopausal&#xD;
             hormone replacement therapy within the last 3 months&#xD;
&#xD;
          -  Immobility&#xD;
&#xD;
          -  Avalvulie&#xD;
&#xD;
          -  Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus,&#xD;
             Haemangiectasia hypertrophicans)&#xD;
&#xD;
          -  State after pulmonary embolism&#xD;
&#xD;
          -  Recognized hypersensitivity to the trial drug ingredients&#xD;
&#xD;
          -  Current florid venous ulcus&#xD;
&#xD;
          -  Clinical indication for a necessary, specific phlebologic acute treatment, e.g.&#xD;
             compressive treatment, phlebectomy, etc.&#xD;
&#xD;
        Previous treatment(s) exclusion criteria:&#xD;
&#xD;
          -  Treatment with venous drugs within the last 4 weeks&#xD;
&#xD;
          -  Changes in, or initiation with, treatment with theophylline, diuretics, cardiac&#xD;
             glycosides, ACE inhibitors or calcium antagonists within the last 8 days&#xD;
&#xD;
        Concomitant treatment/non-drug therapy exclusion criteria:&#xD;
&#xD;
          -  Other venous drugs apart from the trial medication&#xD;
&#xD;
          -  Compression bandages&#xD;
&#xD;
          -  Venous surgery of the leg used for the fluxmetry&#xD;
&#xD;
          -  Extensive use (i.e. on more than a total of 6 days during the entire trial) of&#xD;
             laxatives which affect fluid or electrolyte balance&#xD;
&#xD;
          -  Major surgery requiring full anesthesia&#xD;
&#xD;
        Other exclusion criteria:&#xD;
&#xD;
          -  Previously studied under this protocol&#xD;
&#xD;
          -  Participation in another clinical trial within the previous 90 days or during the&#xD;
             present study&#xD;
&#xD;
          -  Patients considered as mentally ill as well as unable to work or with limited working&#xD;
             ability, or unable (or only partially able) to follow the spoken or written&#xD;
             explanations concerning the trial&#xD;
&#xD;
          -  Patients in a bad general health state according to the investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.3_U03-1092.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 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/NCT02191163
org study id: 1138.3
nct id: NCT02191163
lead sponsor: 
Study to determine the efficacy and safety of Antistax® film coated tablets in improving
      microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Changes from baseline in the resting flux
time frame: Baseline, after 6 weeks of treatment
description: measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry
measure: Changes from baseline in the resting flux
time frame: Baseline, after 3 weeks of treatment
description: measured in the frequency range 10-37 kHz
measure: Changes in the resting flux
time frame: Baseline, after 3 and 6 weeks of treatment
description: measured in the frequency range <10 kHz
measure: Changes in the combined resting fluxes (<37 kHz)
time frame: Baseline, after 3 and 6 weeks of treatment
measure: Changes in the transcutaneous oximetry (TcPO2)
time frame: Baseline, after 3 and 6 weeks of treatment
description: measured on the inside lower leg of the more CVI-affected leg
measure: Change from baseline in the calf circumference of the most affected leg
time frame: Baseline, after 3 and 6 weeks of treatment
measure: Change from baseline in the ankle circumference of the most affected leg
time frame: Baseline, after 3 and 6 weeks of treatment
measure: Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
time frame: Baseline, after 3 and 6 weeks of treatment
measure: Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
time frame: after 6 weeks of treatment
measure: Global efficacy assessment by investigator on a 4-point VRS
time frame: after 6 weeks of treatment
measure: Number of patients with adverse events
time frame: up to 16 weeks
measure: Number of patients with clinically relevant changes in laboratory values
time frame: Baseline, up to 16 weeks
measure: Number of patients with clinically significant changes in vital signs
time frame: Baseline, up to 16 weeks
measure: Global tolerability assessment by investigator on a 4-point VRS
time frame: after 6 weeks of treatment
measure: Global tolerability assessment by patient on a 4-point VRS
time frame: after 6 weeks of treatment
arm group label: Antistax®
arm group type: Experimental
description: 1 x 360 mg for 42 days
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Antistax®
arm group label: Antistax®
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.3_U03-1092.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Venous Insufficiency