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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Venous Insufficiency

Treatments

Drug: Antistax®

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02191163

1138.3

Details and patient eligibility

About

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)

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No 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