Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency

Study Overview
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Brief Summary
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Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location, Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)

Official Title
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A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax® Film Coated Tablets, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Drug: Antistax®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older CVI, Clinical Class 3 (oedema) or 4a (mild skin changes ascribed to venous disease, e.g. pigmentation), according to the CEAP classification Willing and able to give written informed consent prior to participation in the study Exclusion Criteria: Concomitant diseases: Decompensated cardiac insufficiency Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency, renal insufficiency, lymphoedema, 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 > 3x upper limit of normal) Other diseases: hyper- or hypocalcaemia, malignancies Anamnestic indications of diabetic microangiopathy or polyneuropathy Drug and/or alcohol abuse Severe climacteric complaints: changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months Immobility Avalvulia Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans) State after pulmonary embolism Recognised hypersensitivity to the trial drug ingredients Current florid venous ulcus Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compression treatment, phlebectomy, etc. Previous treatments: Patients who are on compression therapy and/or are wearing support stockings and who optimally benefit from these measures Treatment with venous drugs within the last 2 weeks prior to the intake of study medication Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks prior to the intake of study medication Concomitant treatment/non-drug therapy exclusion criteria: Other venous drugs apart from the trial medication Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry Extensive use of laxatives Major surgery requiring full anaesthesia Other exclusion criteria: Previously studied under this protocol Participation in another clinical trial within the previous 90 days or during the present study Patient is investigator, co-investigator, or study nurse in this study Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only) 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 judgement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antistax®<br>1 tablet per day for 12 weeks | Drug: Antistax®<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in limb volume determination | water displacement method | Baseline, day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in limb volume determination | water displacement method | Baseline, day 21 and day 42 | 
| Changes in the calf circumference | in centimeters | Baseline, at day 21, 42 and 84 | 
| Changes in the ankle circumference | in centimeters | Baseline, at day 21, 42, and 84 | 
| Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS) |  | Baseline, at day 21, 42, and 84 | 
| Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS) |  | day 84 | 
| Global assessment of efficacy by the investigator on a 4-point VRS |  | day 84 | 
| Global assessment of tolerability by the patient on a 4-point VRS |  | day 84 | 
| Global assessment of tolerability by the investigator on a 4-point VRS |  | Day 84 | 
| Number of patients with adverse events |  | up to 12 weeks | 
| Number of patients with clinically significant changes in laboratory values |  | Baseline, week 12 | 
| Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR)) |  | Baseline, up to 12 weeks |