Clinical trial NCT02191254: Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in limb volume determination
timeFrame: Baseline, day 84
Secondary outcomes:
measure: Changes in limb volume determination
timeFrame: Baseline, day 21 and day 42
measure: Changes in the calf circumference
timeFrame: Baseline, at day 21, 42 and 84
measure: Changes in the ankle circumference
timeFrame: Baseline, at day 21, 42, and 84
measure: Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
timeFrame: Baseline, at day 21, 42, and 84
measure: Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS)
timeFrame: day 84
measure: Global assessment of efficacy by the investigator on a 4-point VRS
timeFrame: day 84
measure: Global assessment of tolerability by the patient on a 4-point VRS
timeFrame: day 84
measure: Global assessment of tolerability by the investigator on a 4-point VRS
timeFrame: Day 84
measure: Number of patients with adverse events
timeFrame: up to 12 weeks
measure: Number of patients with clinically significant changes in laboratory values
timeFrame: Baseline, week 12
measure: Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
timeFrame: Baseline, up to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
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.