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Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency

Primary Purpose

Venous Insufficiency

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Antistax®
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female
  • >= 18 years of age
  • CVI I or CVI II (without expanded trophic disturbances)
  • Willing and able to give written informed consent in accordance to Good Clinical Practice and local legislation prior to participation in the study

Exclusion Criteria:

Concomitant disease(s) exclusion criteria:

  • Decompensated cardiac insufficiency
  • Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc)
  • Peripheral arterial disease (ankle/arm pressure index < 0.9)
  • Current acute phlebitis or thrombosis
  • Renal insufficiency (Serum creatinine > 1.5 mg/dl)
  • Liver disease (SGPT (ALAT) > 3x upper limit of normal)
  • Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies
  • Anamnestic indications of diabetic microangiopathy or polyneuropathy
  • Drug and/or alcohol abuse
  • Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
  • Severe climacteric complaints or changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months
  • Immobility
  • Avalvulie
  • Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
  • State after pulmonary embolism
  • Recognized hypersensitivity to the trial drug ingredients
  • Current florid venous ulcus
  • Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

  • Treatment with venous drugs within the last 4 weeks
  • Changes in, or initiation with, treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days

Concomitant treatment/non-drug therapy exclusion criteria:

  • Other venous drugs apart from the trial medication
  • Compression bandages
  • Venous surgery of the leg used for the fluxmetry
  • Extensive use (i.e. on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
  • Major surgery requiring full anesthesia

Other exclusion criteria:

  • Previously studied under this protocol
  • Participation in another clinical trial within the previous 90 days or during the present study
  • Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
  • Patients in a bad general health state according to the investigator's judgment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Antistax®

    Placebo

    Arm Description

    1 x 360 mg for 42 days

    Outcomes

    Primary Outcome Measures

    Changes from baseline in the resting flux
    measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry

    Secondary Outcome Measures

    Changes from baseline in the resting flux
    measured in the frequency range 10-37 kHz
    Changes in the resting flux
    measured in the frequency range <10 kHz
    Changes in the combined resting fluxes (<37 kHz)
    Changes in the transcutaneous oximetry (TcPO2)
    measured on the inside lower leg of the more CVI-affected leg
    Change from baseline in the calf circumference of the most affected leg
    Change from baseline in the ankle circumference of the most affected leg
    Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
    Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
    Global efficacy assessment by investigator on a 4-point VRS
    Number of patients with adverse events
    Number of patients with clinically relevant changes in laboratory values
    Number of patients with clinically significant changes in vital signs
    Global tolerability assessment by investigator on a 4-point VRS
    Global tolerability assessment by patient on a 4-point VRS

    Full Information

    First Posted
    July 15, 2014
    Last Updated
    July 15, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02191163
    Brief Title
    Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    August 2002 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief Summary
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antistax®
    Arm Type
    Experimental
    Arm Description
    1 x 360 mg for 42 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Antistax®
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Changes from baseline in the resting flux
    Description
    measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry
    Time Frame
    Baseline, after 6 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Changes from baseline in the resting flux
    Description
    measured in the frequency range 10-37 kHz
    Time Frame
    Baseline, after 3 weeks of treatment
    Title
    Changes in the resting flux
    Description
    measured in the frequency range <10 kHz
    Time Frame
    Baseline, after 3 and 6 weeks of treatment
    Title
    Changes in the combined resting fluxes (<37 kHz)
    Time Frame
    Baseline, after 3 and 6 weeks of treatment
    Title
    Changes in the transcutaneous oximetry (TcPO2)
    Description
    measured on the inside lower leg of the more CVI-affected leg
    Time Frame
    Baseline, after 3 and 6 weeks of treatment
    Title
    Change from baseline in the calf circumference of the most affected leg
    Time Frame
    Baseline, after 3 and 6 weeks of treatment
    Title
    Change from baseline in the ankle circumference of the most affected leg
    Time Frame
    Baseline, after 3 and 6 weeks of treatment
    Title
    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
    Title
    Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
    Time Frame
    after 6 weeks of treatment
    Title
    Global efficacy assessment by investigator on a 4-point VRS
    Time Frame
    after 6 weeks of treatment
    Title
    Number of patients with adverse events
    Time Frame
    up to 16 weeks
    Title
    Number of patients with clinically relevant changes in laboratory values
    Time Frame
    Baseline, up to 16 weeks
    Title
    Number of patients with clinically significant changes in vital signs
    Time Frame
    Baseline, up to 16 weeks
    Title
    Global tolerability assessment by investigator on a 4-point VRS
    Time Frame
    after 6 weeks of treatment
    Title
    Global tolerability assessment by patient on a 4-point VRS
    Time Frame
    after 6 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female >= 18 years of age CVI I or CVI II (without expanded trophic disturbances) Willing and able to give written informed consent in accordance to Good Clinical Practice and local legislation prior to participation in the study Exclusion Criteria: Concomitant disease(s) exclusion criteria: Decompensated cardiac insufficiency Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc) Peripheral arterial disease (ankle/arm pressure index < 0.9) Current acute phlebitis or thrombosis Renal insufficiency (Serum creatinine > 1.5 mg/dl) Liver disease (SGPT (ALAT) > 3x upper limit of normal) Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies Anamnestic indications of diabetic microangiopathy or polyneuropathy Drug and/or alcohol abuse Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only) Severe climacteric complaints or changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months Immobility Avalvulie Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans) State after pulmonary embolism Recognized hypersensitivity to the trial drug ingredients Current florid venous ulcus Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc. Previous treatment(s) exclusion criteria: Treatment with venous drugs within the last 4 weeks Changes in, or initiation with, treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days Concomitant treatment/non-drug therapy exclusion criteria: Other venous drugs apart from the trial medication Compression bandages Venous surgery of the leg used for the fluxmetry Extensive use (i.e. on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance Major surgery requiring full anesthesia Other exclusion criteria: Previously studied under this protocol Participation in another clinical trial within the previous 90 days or during the present study Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial Patients in a bad general health state according to the investigator's judgment

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33141449
    Citation
    Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.
    Results Reference
    derived
    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.3_U03-1092.pdf
    Description
    Related Info

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    Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency

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