Clinical trial NCT02191280: Antistax® in Patients With Chronic Venous Insufficiency
Official title: The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 260
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II


Eligibility criteria: Inclusion Criteria:

* Male or female
* Between 25 and 75 years of age
* CVI I or CVI II (without expanded trophic disturbances)
* Willing and able to give written informed consent 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
* Severe climacteric complaints
* Immobility
* Avalvulia
* 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
* Treatment with laxatives which affect fluid or electrolyte balance within the last 8 days
* Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days
* Changes in post-menopausal Hormone replacement within the last 2 months

Concomitant treatment/non-drug therapy exclusion criteria:

* Other venous drugs apart from the trial medication
* Compression therapy
* Venous surgery at the leg(s)
* Extensive use (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 who have visited a sauna or had other thermal applications in the previous day before any visit
* 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 judgment

Primary outcomes:
measure: Changes from baseline of limb volume
timeFrame: Baseline, day 84
Secondary outcomes:
measure: Changes of limb volume
timeFrame: Baseline, days 42 and 98
measure: Measurement of calf circumference
timeFrame: Baseline, days 42, 84 and 98
measure: Measurement of ankle circumference
timeFrame: Baseline, days 42, 84 and 98
measure: Assessment of subjective symptoms on a visual analogue scale (VAS)
timeFrame: Baseline, days 42, 84 and 98
measure: Assessment of global efficacy by patient on a 4-point verbal rating scale
timeFrame: days 42, 84 and 98
measure: Assessment of global efficacy by investigator on a 4-point verbal rating scale
timeFrame: days 42, 84 and 98
measure: Assessment of global tolerability by patient on a 4-point verbal rating scale
timeFrame: days 42, 84 and 98
measure: Assessment of global tolerability by investigator on a 4-point verbal rating scale
timeFrame: days 42, 84 and 98
measure: Number of patients with adverse events
timeFrame: up to 14 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.