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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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ClinicalTrials.gov Identifier: NCT02191163
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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)

Condition or disease Intervention/treatment Phase
Venous Insufficiency Drug: Antistax® Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2002
Actual Primary Completion Date : August 2002

Arm Intervention/treatment
Experimental: Antistax®
1 x 360 mg for 42 days
Drug: Antistax®
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Changes from baseline in the resting flux [ Time Frame: Baseline, after 6 weeks of treatment ]
    measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry


Secondary Outcome Measures :
  1. Changes from baseline in the resting flux [ Time Frame: Baseline, after 3 weeks of treatment ]
    measured in the frequency range 10-37 kHz

  2. Changes in the resting flux [ Time Frame: Baseline, after 3 and 6 weeks of treatment ]
    measured in the frequency range <10 kHz

  3. Changes in the combined resting fluxes (<37 kHz) [ Time Frame: Baseline, after 3 and 6 weeks of treatment ]
  4. Changes in the transcutaneous oximetry (TcPO2) [ Time Frame: Baseline, after 3 and 6 weeks of treatment ]
    measured on the inside lower leg of the more CVI-affected leg

  5. Change from baseline in the calf circumference of the most affected leg [ Time Frame: Baseline, after 3 and 6 weeks of treatment ]
  6. Change from baseline in the ankle circumference of the most affected leg [ Time Frame: Baseline, after 3 and 6 weeks of treatment ]
  7. 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 ]
  8. Global efficacy assessment by patient on a 4-point verbal rating scale (VRS) [ Time Frame: after 6 weeks of treatment ]
  9. Global efficacy assessment by investigator on a 4-point VRS [ Time Frame: after 6 weeks of treatment ]
  10. Number of patients with adverse events [ Time Frame: up to 16 weeks ]
  11. Number of patients with clinically relevant changes in laboratory values [ Time Frame: Baseline, up to 16 weeks ]
  12. Number of patients with clinically significant changes in vital signs [ Time Frame: Baseline, up to 16 weeks ]
  13. Global tolerability assessment by investigator on a 4-point VRS [ Time Frame: after 6 weeks of treatment ]
  14. Global tolerability assessment by patient on a 4-point VRS [ Time Frame: after 6 weeks of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191163     History of Changes
Other Study ID Numbers: 1138.3
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases